A Phase 1 Clinical Trial in Healthy Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of TERN-701, the Effects of Food, Acid-Reducing Agents, and Drug-Drug Interactions, and the Relative Bioavailability of New Tablet Formulations of TERN-701
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 196
- Locations
- 1
- Primary Endpoint
- Number of Participants Who Experience a Treatment Emergent Adverse Event (AE)
Study Overview
Brief Summary
The goal of the study is to learn what happens to different doses and forms of TERN-701 in a healthy person's body over time. Researchers will compare what happens to different doses and forms of TERN-701 in a person's body over time when given with or without food, or with or without other medications.
The goal of the study is to learn:
- What happens to different doses of TERN-701 in a person's body over time when it is given with or without food, or with or without other medications.
- About the safety of TERN-701 and if people tolerate it
Detailed Description
Per protocol, participants will be randomized in Cohort 7 to the sequence in which they receive two TERN-701 formulations. All other cohorts will be non-randomized.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •The main inclusion criteria include but are not limited to the following:
- •Has body weight ≥48 kg (105.6 lbs) and body mass index within the range of 18.5 to 32 kg/m^2 (inclusive)
- •Is in good health
Exclusion Criteria
- •The main exclusion criteria include but are not limited to the following:
- •Has history or clinical manifestation of any metabolic, allergic, autoimmune, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, ocular, respiratory, endocrine, or psychiatric disorder, or any condition that would affect drug absorption, distribution, metabolism, or excretion (eg, stomach or intestinal surgery, or gallbladder removal/cholecystectomy). Uncomplicated appendectomy and hernia repair will be allowed.
- •Has history of QT prolongation syndrome, unexplained syncope, family history of sudden death, atrial fibrillation, malignant tumor, mental disorder, or any major disease
- •Has positive screening test for Hepatitis B surface antigen, anti-Hepatitis C virus antibodies, or anti-Human immunodeficiency virus (HIV) 1 and 2 antibodies
- •Has any known history of bleeding, or prothrombin time (TERN-701 + Probe Substrate Cocktail-2 arm only)
Arms & Interventions
Cohort 10: SAD Escalation of TERN-701 Dose Level 8
Participants receive a single oral dose of TERN-701 Dose Level 8 under fasted conditions on Day 1.
Intervention: TERN-701 (Drug)
Cohort 11: SAD Escalation of TERN-701 Dose Level 9
Participants receive a single oral dose of TERN-701 Dose Level 9 under fasted conditions on Day 1.
Intervention: TERN-701 (Drug)
Cohort 13: Multiple Ascending Dose (MAD) Escalation of TERN-701 Dose Level 4
Participants receive an oral dose of TERN-701 Dose Level 4 once daily from Day 1 to Day 13 under fasted conditions.
Intervention: TERN-701 (Drug)
Cohort 1: Single Ascending Dose (SAD) Escalation of TERN-701 Dose Level 1
Participants receive a single oral dose of TERN-701 Dose Level 1 under fasted conditions on Day 1.
Intervention: TERN-701 (Drug)
Cohort 2: SAD Escalation of TERN-701 Dose Level 2
Participants receive a single oral dose of TERN-701 Dose Level 2 under fasted conditions on Day 1.
Intervention: TERN-701 (Drug)
Cohort 4: SAD Escalation of TERN-701 Dose Level 4
Participants receive a single oral dose of TERN-701 Dose Level 4 under fasted conditions on Day 1.
Intervention: TERN-701 (Drug)
Cohort 5: SAD Escalation of TERN-701 Dose Level 5
Participants receive a single oral dose of TERN-701 Dose Level 5 under fasted conditions on Day 1.
Intervention: TERN-701 (Drug)
Cohort 6: SAD Escalation of TERN-701 Dose Level 7
Participants receive a single oral dose of TERN-701 Dose Level 7 under fasted conditions on Day 1.
Intervention: TERN-701 (Drug)
Cohort 7: TERN-701 Formulations with Rabeprazole 20 mg
Participants in Cohort 7 are randomized to receive TERN-701 Formulation 1 or Formulation 2 at Dose Level 5 on Day 1. On Day 7, participants receive TERN-701 Formulation 2 or Formulation 1 at Dose Level 5. Participants also receive Rabeprazole 20 mg once daily on Days 10-13. On Day 14, participants will co-administer a single oral dose of Rabeprazole 20 mg with TERN-701 Formulation 1 Dose Level 5 at the same time. All participants receive treatment under fasted conditions.
Intervention: TERN-701 (Drug)
Cohort 7: TERN-701 Formulations with Rabeprazole 20 mg
Participants in Cohort 7 are randomized to receive TERN-701 Formulation 1 or Formulation 2 at Dose Level 5 on Day 1. On Day 7, participants receive TERN-701 Formulation 2 or Formulation 1 at Dose Level 5. Participants also receive Rabeprazole 20 mg once daily on Days 10-13. On Day 14, participants will co-administer a single oral dose of Rabeprazole 20 mg with TERN-701 Formulation 1 Dose Level 5 at the same time. All participants receive treatment under fasted conditions.
Intervention: Rabeprazole (Drug)
Cohort 8: TERN-701 + Probe Substrate Cocktail-1
Per protocol, the probe substrate cocktail-1 consists of midazolam 2 mg, digoxin 0.25 mg, pravastatin 40 mg, montelukast 10 mg, and omeprazole 40 mg. On Day 1, participants receive a single oral dose of the probe substrate cocktail-1 under fasted conditions. On Day 5, participants receive a single oral dose of TERN-701 Dose Level 4 co-administered with a single oral dose of the probe substrate cocktail-1 taken at the same time under fasted conditions. On Day 9, participants receive a single oral dose of TERN-701 Dose Level 7 co-administered with a single oral dose of the probe substrate cocktail-1 taken at the same time under fasted conditions.
Intervention: Omeprazole (Drug)
Cohort 9: TERN-701 Dose Level 5 + Rabeprazole 20 mg
Participants receive a single oral dose of TERN-701 Dose Level 5 on Day 1 under fasted conditions. On Days 4-7 participants will receive Rabeprazole 20 mg once daily under fasted conditions. On Day 8, under fasted conditions, participants co-administer a single oral dose of TERN-701 Dose Level 5 with a single oral dose of Rabeprazole 20 mg taken at the same time under fasted conditions.
Intervention: TERN-701 (Drug)
Cohort 8: TERN-701 + Probe Substrate Cocktail-1
Per protocol, the probe substrate cocktail-1 consists of midazolam 2 mg, digoxin 0.25 mg, pravastatin 40 mg, montelukast 10 mg, and omeprazole 40 mg. On Day 1, participants receive a single oral dose of the probe substrate cocktail-1 under fasted conditions. On Day 5, participants receive a single oral dose of TERN-701 Dose Level 4 co-administered with a single oral dose of the probe substrate cocktail-1 taken at the same time under fasted conditions. On Day 9, participants receive a single oral dose of TERN-701 Dose Level 7 co-administered with a single oral dose of the probe substrate cocktail-1 taken at the same time under fasted conditions.
Intervention: Midazolam (Drug)
Cohort 8: TERN-701 + Probe Substrate Cocktail-1
Per protocol, the probe substrate cocktail-1 consists of midazolam 2 mg, digoxin 0.25 mg, pravastatin 40 mg, montelukast 10 mg, and omeprazole 40 mg. On Day 1, participants receive a single oral dose of the probe substrate cocktail-1 under fasted conditions. On Day 5, participants receive a single oral dose of TERN-701 Dose Level 4 co-administered with a single oral dose of the probe substrate cocktail-1 taken at the same time under fasted conditions. On Day 9, participants receive a single oral dose of TERN-701 Dose Level 7 co-administered with a single oral dose of the probe substrate cocktail-1 taken at the same time under fasted conditions.
Intervention: TERN-701 (Drug)
Cohort 8: TERN-701 + Probe Substrate Cocktail-1
Per protocol, the probe substrate cocktail-1 consists of midazolam 2 mg, digoxin 0.25 mg, pravastatin 40 mg, montelukast 10 mg, and omeprazole 40 mg. On Day 1, participants receive a single oral dose of the probe substrate cocktail-1 under fasted conditions. On Day 5, participants receive a single oral dose of TERN-701 Dose Level 4 co-administered with a single oral dose of the probe substrate cocktail-1 taken at the same time under fasted conditions. On Day 9, participants receive a single oral dose of TERN-701 Dose Level 7 co-administered with a single oral dose of the probe substrate cocktail-1 taken at the same time under fasted conditions.
Intervention: Digoxin (Drug)
Cohort 8: TERN-701 + Probe Substrate Cocktail-1
Per protocol, the probe substrate cocktail-1 consists of midazolam 2 mg, digoxin 0.25 mg, pravastatin 40 mg, montelukast 10 mg, and omeprazole 40 mg. On Day 1, participants receive a single oral dose of the probe substrate cocktail-1 under fasted conditions. On Day 5, participants receive a single oral dose of TERN-701 Dose Level 4 co-administered with a single oral dose of the probe substrate cocktail-1 taken at the same time under fasted conditions. On Day 9, participants receive a single oral dose of TERN-701 Dose Level 7 co-administered with a single oral dose of the probe substrate cocktail-1 taken at the same time under fasted conditions.
Intervention: Montelukast (Drug)
Cohort 3: SAD Escalation of TERN-701 Dose Level 3 and Food Effect
On Period 1 Day 1, participants receive a single oral dose of TERN-701 Dose Level 3 under fasted conditions. On Period 2 Day 1, participants receive TERN-701 Dose Level 3 after a high-fat meal.
Intervention: TERN-701 (Drug)
Cohort 8: TERN-701 + Probe Substrate Cocktail-1
Per protocol, the probe substrate cocktail-1 consists of midazolam 2 mg, digoxin 0.25 mg, pravastatin 40 mg, montelukast 10 mg, and omeprazole 40 mg. On Day 1, participants receive a single oral dose of the probe substrate cocktail-1 under fasted conditions. On Day 5, participants receive a single oral dose of TERN-701 Dose Level 4 co-administered with a single oral dose of the probe substrate cocktail-1 taken at the same time under fasted conditions. On Day 9, participants receive a single oral dose of TERN-701 Dose Level 7 co-administered with a single oral dose of the probe substrate cocktail-1 taken at the same time under fasted conditions.
Intervention: Pravastatin (Drug)
Cohort 9: TERN-701 Dose Level 5 + Rabeprazole 20 mg
Participants receive a single oral dose of TERN-701 Dose Level 5 on Day 1 under fasted conditions. On Days 4-7 participants will receive Rabeprazole 20 mg once daily under fasted conditions. On Day 8, under fasted conditions, participants co-administer a single oral dose of TERN-701 Dose Level 5 with a single oral dose of Rabeprazole 20 mg taken at the same time under fasted conditions.
Intervention: Rabeprazole (Drug)
Cohort 12: TERN-701 Dose Level 3 + Itraconazole 200 mg
Participants receive a single oral dose of TERN-701 at Dose Level 3 under nonfasted conditions on Day 1. On Day 8, participants will receive Itraconazole 200 mg twice daily after a standardized breakfast and evening snack. On Days 9-11, participants will take a single oral dose of Itraconazole 200 mg after a standardized meal. On Day 12, participants will take a single dose of Itraconazole 200mg after a standardized meal followed by TERN-701 Dose Level 3 taken an hour later. Participants will continue taking a single oral dose of Itraconazole 200 mg once daily after a standardized meal on Days 13-15.
Intervention: TERN-701 (Drug)
Cohort 12: TERN-701 Dose Level 3 + Itraconazole 200 mg
Participants receive a single oral dose of TERN-701 at Dose Level 3 under nonfasted conditions on Day 1. On Day 8, participants will receive Itraconazole 200 mg twice daily after a standardized breakfast and evening snack. On Days 9-11, participants will take a single oral dose of Itraconazole 200 mg after a standardized meal. On Day 12, participants will take a single dose of Itraconazole 200mg after a standardized meal followed by TERN-701 Dose Level 3 taken an hour later. Participants will continue taking a single oral dose of Itraconazole 200 mg once daily after a standardized meal on Days 13-15.
Intervention: Itraconazole (Drug)
Cohort 14: TERN-701 Dose Level 5 + Probe Substrate Cocktail-2
Per protocol, the probe substrate cocktail-2 consists of midazolam 2 mg, warfarin 5 mg, and rosuvastatin 10 mg. Participants receive a single oral dose of the Probe Substrate Cocktail-2 on Day 1 under fasted conditions. On Days 9-15, participants receive a single oral dose of TERN-701 Dose Level 5 once daily under fasted conditions. On Day 16, participants receive a single oral dose of the Probe Substrate Cocktail-2 co-administered with TERN-701 Dose Level 5 taken at the same time under fasted conditions. On Days 17-21 participants receive TERN-701 Dose Level 5 as a single oral dose once daily under fasted conditions.
Intervention: TERN-701 (Drug)
Cohort 14: TERN-701 Dose Level 5 + Probe Substrate Cocktail-2
Per protocol, the probe substrate cocktail-2 consists of midazolam 2 mg, warfarin 5 mg, and rosuvastatin 10 mg. Participants receive a single oral dose of the Probe Substrate Cocktail-2 on Day 1 under fasted conditions. On Days 9-15, participants receive a single oral dose of TERN-701 Dose Level 5 once daily under fasted conditions. On Day 16, participants receive a single oral dose of the Probe Substrate Cocktail-2 co-administered with TERN-701 Dose Level 5 taken at the same time under fasted conditions. On Days 17-21 participants receive TERN-701 Dose Level 5 as a single oral dose once daily under fasted conditions.
Intervention: Warfarin (Drug)
Cohort 14: TERN-701 Dose Level 5 + Probe Substrate Cocktail-2
Per protocol, the probe substrate cocktail-2 consists of midazolam 2 mg, warfarin 5 mg, and rosuvastatin 10 mg. Participants receive a single oral dose of the Probe Substrate Cocktail-2 on Day 1 under fasted conditions. On Days 9-15, participants receive a single oral dose of TERN-701 Dose Level 5 once daily under fasted conditions. On Day 16, participants receive a single oral dose of the Probe Substrate Cocktail-2 co-administered with TERN-701 Dose Level 5 taken at the same time under fasted conditions. On Days 17-21 participants receive TERN-701 Dose Level 5 as a single oral dose once daily under fasted conditions.
Intervention: Midazolam (Drug)
Cohort 14: TERN-701 Dose Level 5 + Probe Substrate Cocktail-2
Per protocol, the probe substrate cocktail-2 consists of midazolam 2 mg, warfarin 5 mg, and rosuvastatin 10 mg. Participants receive a single oral dose of the Probe Substrate Cocktail-2 on Day 1 under fasted conditions. On Days 9-15, participants receive a single oral dose of TERN-701 Dose Level 5 once daily under fasted conditions. On Day 16, participants receive a single oral dose of the Probe Substrate Cocktail-2 co-administered with TERN-701 Dose Level 5 taken at the same time under fasted conditions. On Days 17-21 participants receive TERN-701 Dose Level 5 as a single oral dose once daily under fasted conditions.
Intervention: Rosuvastatin (Drug)
Cohort 15: TERN-701 Dose Level 8 + Probe Substrate Cocktail-2
Per protocol, the probe substrate cocktail-2 consists of midazolam 2 mg, warfarin 5 mg, and rosuvastatin 10 mg. Participants receive a single oral dose of the Probe Substrate Cocktail-2 on Day 1 under fasted conditions. On Days 9-15, participants receive a single oral dose of TERN-701 Dose Level 8 once daily under fasted conditions. On Day 16, participants receive a single oral dose of the Probe Substrate Cocktail-2 co-administered with TERN-701 Dose Level 8 taken at the same time under fasted conditions. On Days 17-21 participants receive TERN-701 Dose Level 8 as a single oral dose once daily under fasted conditions.
Intervention: TERN-701 (Drug)
Cohort 15: TERN-701 Dose Level 8 + Probe Substrate Cocktail-2
Per protocol, the probe substrate cocktail-2 consists of midazolam 2 mg, warfarin 5 mg, and rosuvastatin 10 mg. Participants receive a single oral dose of the Probe Substrate Cocktail-2 on Day 1 under fasted conditions. On Days 9-15, participants receive a single oral dose of TERN-701 Dose Level 8 once daily under fasted conditions. On Day 16, participants receive a single oral dose of the Probe Substrate Cocktail-2 co-administered with TERN-701 Dose Level 8 taken at the same time under fasted conditions. On Days 17-21 participants receive TERN-701 Dose Level 8 as a single oral dose once daily under fasted conditions.
Intervention: Midazolam (Drug)
Cohort 15: TERN-701 Dose Level 8 + Probe Substrate Cocktail-2
Per protocol, the probe substrate cocktail-2 consists of midazolam 2 mg, warfarin 5 mg, and rosuvastatin 10 mg. Participants receive a single oral dose of the Probe Substrate Cocktail-2 on Day 1 under fasted conditions. On Days 9-15, participants receive a single oral dose of TERN-701 Dose Level 8 once daily under fasted conditions. On Day 16, participants receive a single oral dose of the Probe Substrate Cocktail-2 co-administered with TERN-701 Dose Level 8 taken at the same time under fasted conditions. On Days 17-21 participants receive TERN-701 Dose Level 8 as a single oral dose once daily under fasted conditions.
Intervention: Warfarin (Drug)
Cohort 15: TERN-701 Dose Level 8 + Probe Substrate Cocktail-2
Per protocol, the probe substrate cocktail-2 consists of midazolam 2 mg, warfarin 5 mg, and rosuvastatin 10 mg. Participants receive a single oral dose of the Probe Substrate Cocktail-2 on Day 1 under fasted conditions. On Days 9-15, participants receive a single oral dose of TERN-701 Dose Level 8 once daily under fasted conditions. On Day 16, participants receive a single oral dose of the Probe Substrate Cocktail-2 co-administered with TERN-701 Dose Level 8 taken at the same time under fasted conditions. On Days 17-21 participants receive TERN-701 Dose Level 8 as a single oral dose once daily under fasted conditions.
Intervention: Rosuvastatin (Drug)
Cohort 16: Food Effect on TERN-701 Dose Level 8 Formulations with Rabeprazole 20 mg
On Period 1 Day 1, participants receive a single oral dose of TERN-701 Formulation 3 Dose Level 8. On Period 1 Day 7, participants receive a single oral dose of TERN-701 Formulation 4 Dose Level 8. On Period 1 Day 13, participants receive a single oral dose of TERN-701 Formulation 5 Dose Level 8. On Period 1 Day 19, participants receive a single oral dose of TERN-701 Formulation 6 Dose Level 8. All Period 1 treatments are administered under fasted conditions. Per protocol, following Period 1, one formulation is selected for Period 2. On Period 2 Day 1, participants receive a single oral dose of the selected TERN-701 formulation Dose Level 8 after a high-fat meal. On Period 2 Days 7-10, participants receive rabeprazole 20 mg once daily under fasted conditions. On Period 2 Day 11, participants receive the selected formulation of TERN-701 Dose Level 8 as a single oral dose, co-administered with the single oral dose of Rabeprazole 20 mg taken at the same time under fasted conditions.
Intervention: Rabeprazole (Drug)
Cohort 16: Food Effect on TERN-701 Dose Level 8 Formulations with Rabeprazole 20 mg
On Period 1 Day 1, participants receive a single oral dose of TERN-701 Formulation 3 Dose Level 8. On Period 1 Day 7, participants receive a single oral dose of TERN-701 Formulation 4 Dose Level 8. On Period 1 Day 13, participants receive a single oral dose of TERN-701 Formulation 5 Dose Level 8. On Period 1 Day 19, participants receive a single oral dose of TERN-701 Formulation 6 Dose Level 8. All Period 1 treatments are administered under fasted conditions. Per protocol, following Period 1, one formulation is selected for Period 2. On Period 2 Day 1, participants receive a single oral dose of the selected TERN-701 formulation Dose Level 8 after a high-fat meal. On Period 2 Days 7-10, participants receive rabeprazole 20 mg once daily under fasted conditions. On Period 2 Day 11, participants receive the selected formulation of TERN-701 Dose Level 8 as a single oral dose, co-administered with the single oral dose of Rabeprazole 20 mg taken at the same time under fasted conditions.
Intervention: TERN-701 (Drug)
Cohort 17: Food Effect on TERN-701 Dose Level 8 Selected Formulation with Rabeprazole 20 mg
Per protocol, a formulation from Cohort 16 Period 1, different from the formulation selected for Cohort 16 Period 2, may be selected to evaluate the effects of food and rabeprazole 20 mg. On Day 1, participants receive a single oral dose of the selected formulation of TERN-701 Dose Level 8 under fasted conditions. On Day 7, participants receive a single oral dose of the selected formulation of TERN-701 Dose Level 8 after a high-fat meal. On Days 13-16, participants receive a single oral dose of rabeprazole 20 mg once daily. On Day 17, participants receive a single oral dose of the selected formulation of TERN-701 Dose Level 8 co-administered with a single oral dose of rabeprazole 20 mg taken at the same time under fasted conditions.
Intervention: TERN-701 (Drug)
Cohort 17: Food Effect on TERN-701 Dose Level 8 Selected Formulation with Rabeprazole 20 mg
Per protocol, a formulation from Cohort 16 Period 1, different from the formulation selected for Cohort 16 Period 2, may be selected to evaluate the effects of food and rabeprazole 20 mg. On Day 1, participants receive a single oral dose of the selected formulation of TERN-701 Dose Level 8 under fasted conditions. On Day 7, participants receive a single oral dose of the selected formulation of TERN-701 Dose Level 8 after a high-fat meal. On Days 13-16, participants receive a single oral dose of rabeprazole 20 mg once daily. On Day 17, participants receive a single oral dose of the selected formulation of TERN-701 Dose Level 8 co-administered with a single oral dose of rabeprazole 20 mg taken at the same time under fasted conditions.
Intervention: Rabeprazole (Drug)
Cohort 18: TERN-701 Dose Level 8 + Bosentan 125 mg
On Day 1, participants receive a single oral dose of TERN-701 Dose Level 8 under fasted conditions. Beginning on Day 8, participants receive an oral dose of Bosentan 125 mg twice daily. On Day 15, participants receive TERN-701 Dose Level 8 as a single oral dose co-administered with the morning dose of Bosentan 125 mg taken at the same time under fasted conditions; participants then receive the second daily dose of Bosentan 125 mg in the evening. Participants continue taking Bosentan 125 mg twice daily on Days 16-18.
Intervention: Bosentan (Drug)
Cohort 19: TERN-701 Dose Level 6 + Quinidine 300 mg
Participants receive a single oral dose of TERN-701 Dose Level 6 on Day 1 under fasted conditions. Beginning on Day 6, participants receive an oral dose of Quinidine 300 mg three times daily. On Day 8, participants receive TERN-701 Dose Level 6 as a single oral dose co-administered with the morning final dose of Quinidine 300 mg taken at the same time under fasted conditions.
Intervention: Quinidine (Drug)
Cohort 18: TERN-701 Dose Level 8 + Bosentan 125 mg
On Day 1, participants receive a single oral dose of TERN-701 Dose Level 8 under fasted conditions. Beginning on Day 8, participants receive an oral dose of Bosentan 125 mg twice daily. On Day 15, participants receive TERN-701 Dose Level 8 as a single oral dose co-administered with the morning dose of Bosentan 125 mg taken at the same time under fasted conditions; participants then receive the second daily dose of Bosentan 125 mg in the evening. Participants continue taking Bosentan 125 mg twice daily on Days 16-18.
Intervention: TERN-701 (Drug)
Cohort 19: TERN-701 Dose Level 6 + Quinidine 300 mg
Participants receive a single oral dose of TERN-701 Dose Level 6 on Day 1 under fasted conditions. Beginning on Day 6, participants receive an oral dose of Quinidine 300 mg three times daily. On Day 8, participants receive TERN-701 Dose Level 6 as a single oral dose co-administered with the morning final dose of Quinidine 300 mg taken at the same time under fasted conditions.
Intervention: TERN-701 (Drug)
Outcomes
Primary Outcomes
Number of Participants Who Experience a Treatment Emergent Adverse Event (AE)
Time Frame: Up to approximately 102 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience a treatment emergent AE will be reported.
Number of Participants Who Discontinue Study Treatment Due to an AE
Time Frame: Up to approximately 102 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
Number of Participants with Abnormal Urinalysis Results Reported as Adverse Events
Time Frame: up to approximately 102 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with abnormal urinalysis-related AEs will be reported.
Number of Participants with Clinically Significant Abnormalities in Systolic Blood Pressure
Time Frame: up to approximately 102 days
Blood pressure will be measured after the participant has been at rest in a supine position for at least 10 minutes. Blood pressure and pulse measurements will be assessed with a completely automated device; manual techniques will be used only if an automated device is not available. Blood pressure measurements will be carried out before blood sample collections or at least 30 minutes after any blood draws.
Number of Participants with Clinically Significant Abnormalities in Diastolic Blood Pressure
Time Frame: up to approximately 102 days
Blood pressure will be measured after the participant has been at rest in a supine position for at least 10 minutes. Blood pressure and pulse measurements will be assessed with a completely automated device; manual techniques will be used only if an automated device is not available. Blood pressure measurements will be carried out before blood sample collections or at least 30 minutes after any blood draws.
Number of Participants with Abnormal Clinical Hematology Test Results Reported as Adverse Events
Time Frame: up to approximately 102 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with abnormal hematology-related AEs will be reported.
Number of Participants with Abnormal Clinical Chemistry Test Results Reported as Adverse Events
Time Frame: up to approximately 102 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with abnormal chemistry-related AEs will be reported.
Number of Participants with Clinically Significant Abnormalities in 12-Lead (ECG) Findings
Time Frame: up to approximately 102 days
During the 12-lead ECG collection participants will be instructed to lie supine for at least 10 minutes prior to ECG collection. During the collection, participants should be in a quiet setting, without distractions, and should refrain from talking or moving their arms or legs. All ECG acquisitions will be carried out before any blood sample collections or at least 30 minutes after any blood draws.
Area Under the Concentration versus Time Curve from Time 0 to the Last Quantifiable Concentration (AUC0-last) of TERN-701 in Plasma
Time Frame: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the AUC0-Last of TERN-701.
Area Under the Concentration versus Time Curve Extrapolated to Infinite Time (AUC0-Inf) of TERN-701 in Plasma
Time Frame: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the AUC0-inf of TERN-701.
Area Under the Concentration versus Time Curve Over the Dosing Interval (AUCtau) of TERN-701 in Plasma
Time Frame: Pre-dose and at designated time points up to 24 hours post dose
Blood samples will be collected to determine the AUCtau of TERN-701.
Maximum Observed Concentration of Drug (Cmax) of TERN-701 in Plasma
Time Frame: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the Cmax of TERN-701.
Apparent Terminal Elimination Half-Life (t1/2) of TERN-701 in Plasma
Time Frame: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the t1/2 of TERN-701.
Time of Maximum Observed Concentration of Drug (Tmax) of TERN-701 in Plasma
Time Frame: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the Tmax of TERN-701.
Secondary Outcomes
- AUC0-last of TERN-701 in Plasma Under Fed Versus Fasted Conditions(Pre-dose and at designated time points up to 96 hours post dose)
- AUC0-Inf of TERN-701 in Plasma Under Fed Versus Fasted Conditions(Pre-dose and at designated time points up to 96 hours post dose)
- Cmax of TERN-701 in Plasma Under Fed Versus Fasted Conditions(Pre-dose and at designated time points up to 96 hours post dose)
- Tmax of TERN-701 in Plasma Under Fed Versus Fasted Conditions(Pre-dose and at designated time points up to 96 hours post dose)
- AUC0-last of TERN-701 Formulations in Plasma(Pre-dose and at designated time points up to 96 hours post dose)
- AUC0-Inf of TERN-701 Formulations in Plasma(Pre-dose and at designated time points up to 96 hours post dose)
- Cmax of TERN-701 Formulations in Plasma(Pre-dose and at designated time points up to 96 hours post dose)
- AUC0-last of TERN-701 in Plasma Administered With or Without an Acid-Reducing Agent(Pre-dose and at designated time points up to 96 hours post dose)
- AUC0-Inf of TERN-701 in Plasma Administered With or Without an Acid-Reducing Agent(Pre-dose and at designated time points up to 96 hours post dose)
- Cmax of TERN-701 in Plasma Administered With or Without an Acid-Reducing Agent(Pre-dose and at designated time points up to 96 hours post dose)
- AUC0-last of Midazolam in Plasma Administered With or Without TERN-701(Pre-dose and at designated time points up to 96 hours post dose)
- AUC0-Inf of Midazolam in Plasma Administered With or Without TERN-701(Pre-dose and at designated time points up to 96 hours post dose)
- Cmax of Midazolam in Plasma Administered With or Without TERN-701(Pre-dose and at designated time points up to 96 hours post dose)
- AUC0-last of Montelukast in Plasma Administered With or Without TERN-701(Pre-dose and at designated time points up to 96 hours post dose)
- AUC0-Inf of Montelukast in Plasma Administered With or Without TERN-701(Pre-dose and at designated time points up to 96 hours post dose)
- Cmax of Montelukast in Plasma Administered With or Without TERN-701(Pre-dose and at designated time points up to 96 hours post dose)
- AUC0-last of Omeprazole in Plasma Administered With or Without TERN-701(Pre-dose and at designated time points up to 96 hours post dose)
- AUC0-Inf of Omeprazole in Plasma Administered With or Without TERN-701(Pre-dose and at designated time points up to 96 hours post dose)
- Cmax of Omeprazole in Plasma Administered With or Without TERN-701(Pre-dose and at designated time points up to 96 hours post dose)
- AUC0-last of Digoxin in Plasma Administered With or Without TERN-701(Pre-dose and at designated time points up to 96 hours post dose)
- AUC0-Inf of Digoxin in Plasma Administered With or Without TERN-701(Pre-dose and at designated time points up to 96 hours post dose)
- Cmax of Digoxin in Plasma Administered With or Without TERN-701(Pre-dose and at designated time points up to 96 hours post dose)
- AUC0-last of Pravastatin in Plasma Administered With or Without TERN-701(Pre-dose and at designated time points up to 96 hours post dose)
- AUC0-Inf of Pravastatin in Plasma Administered With or Without TERN-701(Pre-dose and at designated time points up to 96 hours post dose)
- Cmax of Pravastatin in Plasma Administered With or Without TERN-701(Pre-dose and at designated time points up to 96 hours post dose)
- AUC0-last of Warfarin in Plasma Administered With or Without TERN-701(Pre-dose and at designated time points up to 96 hours post dose)
- AUC0-Inf of Warfarin in Plasma Administered With or Without TERN-701(Pre-dose and at designated time points up to 96 hours post dose)
- Cmax of Warfarin in Plasma Administered With or Without TERN-701(Pre-dose and at designated time points up to 96 hours post dose)
- AUC0-last of Rosuvastatin in Plasma Administered With or Without TERN-701(Pre-dose and at designated time points up to 96 hours post dose)
- AUC0-Inf of Rosuvastatin in Plasma Administered With or Without TERN-701(Pre-dose and at designated time points up to 96 hours post dose)
- Cmax of Rosuvastatin in Plasma Administered With or Without TERN-701(Pre-dose and at designated time points up to 96 hours post dose)
- AUC0-last of TERN-701 in Plasma Administered With or Without Itraconazole(Pre-dose and at designated time points up to 96 hours post dose)
- AUC0-Inf of TERN-701 in Plasma Administered With or Without Itraconazole(Pre-dose and at designated time points up to 96 hours post dose)
- Cmax of TERN-701 in Plasma Administered With or Without Itraconazole(Pre-dose and at designated time points up to 96 hours post dose)
- AUC0-last of TERN-701 in Plasma Administered With or Without Bosentan(Pre-dose and at designated time points up to 96 hours post dose)
- AUC0-Inf of TERN-701 in Plasma Administered With or Without Bosentan(Pre-dose and at designated time points up to 96 hours post dose)
- Cmax of TERN-701 in Plasma Administered With or Without Bosentan(Pre-dose and at designated time points up to 96 hours post dose)
- AUC0-last of TERN-701 in Plasma Administered With or Without Quinidine(Pre-dose and at designated time points up to 96 hours post dose)
- AUC0-Inf of TERN-701 in Plasma Administered With or Without Quinidine(Pre-dose and at designated time points up to 96 hours post dose)
- Cmax of TERN-701 in Plasma Administered With or Without Quinidine(Pre-dose and at designated time points up to 96 hours post dose)