A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-68179280 in Healthy Participants
Overview
- Phase
- Phase 1
- Intervention
- JNJ-68179280
- Conditions
- Healthy
- Sponsor
- Janssen Research & Development, LLC
- Enrollment
- 94
- Locations
- 1
- Primary Endpoint
- Number of Participants with Treatment-emergent Adverse Events (TEAEs)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of JNJ-68179280 compared with placebo after administration of single ascending oral doses of JNJ-68179280 administered to healthy participants (Part 1), multiple ascending oral doses of JNJ-68179280, administered to healthy participants once daily (Cohorts 1 through 4) or twice daily (Cohort 5) over 14 consecutive days (Part 2) and multiple ascending oral doses of an alternative JNJ-68179280 formulation, administered to healthy participants once daily over 14 consecutive days (Part 3 if conducted).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy on the basis of physical examination, medical history, vital signs, and 12 lead electrocardiogram (ECG) performed at screening. Any abnormalities must be considered not clinically significant and this determination must be recorded in the participant's source documents and initialed by the investigator
- •Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel (excluding liver enzymes) including hematology, blood coagulation, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
- •Have the following pre study intervention clinical laboratory values during screening and check-in to the unit (Day -2 or Day -1): a. aspartate transaminase (AST) less than or equal to (\<=) upper limit of normal (ULN), b. alanine aminotransferase (ALT) \<= ULN, c. bilirubin \<= ULN, d. alkaline phosphatase \<= ULN, e. gamma-glutamyl transpeptidase (GGTP) \<= ULN, f. albumin greater than or equal to (\>=) lower limit of normal (LLN)
- •A woman must have a negative highly sensitive serum beta-human chorionic gonadotropin (beta-hCG) at screening and a negative urine pregnancy test at check-in to the unit on Day -2 or Day -1
- •Must be a non-smoker (not smoked for at least 6 months prior to screening) and has not used nicotine-containing products (example: nicotine patch, vaping, hookah) for 3 months prior to screening
Exclusion Criteria
- •History of liver or renal insufficiency significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- •History of malignancy before screening (exceptions are squamous or basal cell carcinomas of the skin and carcinoma in situ of the cervix as long as they are considered cured with minimal risk of recurrence)
- •Has an active, acute or chronic infection
- •Has taken any disallowed therapies, concomitant therapy before the planned first dose of study intervention
- •Has a positive urine drug screen and/or alcohol breath test during screening or on Day 2
Arms & Interventions
Part 1: Single Ascending Dose (SAD)
Participants will receive a single ascending oral dose of JNJ-68179280 or placebo capsules under fasted condition (Cohort 1, 2 and 5) and under fasted-fed condition (either Cohort 3 or 4) on Day 1. In 1 of the study cohorts 3 or 4, participants will also receive study intervention on Day 8 under fed condition. One additional optional Cohort 6 may be dosed to assess the safety and pharmacokinetics (PK) of an alternate dose of formulation A under fasted condition.
Intervention: JNJ-68179280
Part 1: Single Ascending Dose (SAD)
Participants will receive a single ascending oral dose of JNJ-68179280 or placebo capsules under fasted condition (Cohort 1, 2 and 5) and under fasted-fed condition (either Cohort 3 or 4) on Day 1. In 1 of the study cohorts 3 or 4, participants will also receive study intervention on Day 8 under fed condition. One additional optional Cohort 6 may be dosed to assess the safety and pharmacokinetics (PK) of an alternate dose of formulation A under fasted condition.
Intervention: Placebo
Part 2: Multiple Ascending Dose (MAD)
Participants will receive multiple ascending oral doses of JNJ-68179280 or placebo capsules once daily in Cohort 1 through 4 or twice daily in Cohort 5 (optional) on Days 1 through 14 under fasted or fed condition.
Intervention: JNJ-68179280
Part 2: Multiple Ascending Dose (MAD)
Participants will receive multiple ascending oral doses of JNJ-68179280 or placebo capsules once daily in Cohort 1 through 4 or twice daily in Cohort 5 (optional) on Days 1 through 14 under fasted or fed condition.
Intervention: Placebo
Part 3: Multiple Dose Alternative Formulation (Optional)
Participants will receive multiple oral doses of an alternative JNJ-68179280 formulation once daily in Cohort 1 and Cohort 2 (optional) on Days 1 through 14 under fasted or fed condition. Doses in Part 3 will depend on the safety, tolerability, PK and pharmacodynamics data from Part 1 and Part 2.
Intervention: JNJ-68179280
Outcomes
Primary Outcomes
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time Frame: Up to 35 days
An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
Number of Participants with Clinically Significant Abnormalities in Vital Signs
Time Frame: Up to 35 days
Number of participants with clinically significant abnormalities in vital signs (including temperature \[oral or tympanic\], pulse/heart rate, respiratory rate, and blood pressure) will be reported.
Number of Participants with Clinically Significant Abnormalities in Physical Examination
Time Frame: Up to 35 days
Number of participants with clinically significant abnormalities in physical examination (including general appearance, respiratory, cardiovascular, assessment through skin or oral mucosa) will be reported.
Number of Participants with Treatment-emergent Serious Adverse Events (SAEs)
Time Frame: Up to 35 days
SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Number of Participants with Clinically Significant Abnormalities in Laboratory Safety Tests
Time Frame: Up to 35 days
Number of participants with clinically significant abnormalities in laboratory safety tests (such as serum chemistry, hematology and urinalysis) will be reported.
Number of Participants with Clinically Significant Abnormalities in 12-lead Electrocardiograms (ECGs)
Time Frame: Up to 28 days
Number of participants with clinically significant abnormalities in ECGs will be reported.
Secondary Outcomes
- Part 1, 2 and 3: Plasma Concentration of JNJ-68179280(Up to 19 days)
- Part 1: Number of Participants with Clinically Significant Abnormalities in Laboratory Safety Tests Under Fasted Condition(Up to 16 days)
- Part 1: Stool Concentration of JNJ-68179280 Under Fasted Condition(Up to Day 6)
- Part 1: Number of Participants with TEAEs Under Fasted Condition(Up to 16 days)
- Part 1: Number of Participants with TEAEs Under Fed Condition(Up to 23 days)
- Part 1: Number of Participants with SAEs Under Fasted Condition(Up to 16 days)
- Part 1: Number of Participants with SAEs Under Fed Condition(Up to 23 days)
- Part 1: Number of Participants with Clinically Significant Abnormalities in Vital Signs Under Fasted Condition(Up to 16 days)
- Part 1, 2 and 3: Urine Concentration of JNJ-68179280(Up to 19 days)
- Part 1, 2 and 3: Stool Concentration of JNJ-68179280(Up to 16 days)
- Part 1: Plasma Concentration of JNJ-68179280 Under Fasted Condition(Up to Day 6)
- Part 1: Plasma Concentration of JNJ-68179280 Under Fed Condition(Up to 13 days)
- Part 1: Stool Concentration of JNJ-68179280 Under Fed Condition(Up to 13 days)
- Part 1: Number of Participants with Clinically Significant Abnormalities in Physical Examination Under Fed Condition(Up to 23 days)
- Part 1: Number of Participants with Clinically Significant Abnormalities in Vital Signs Under Fed Condition(Up to 23 days)
- Part 1: Number of Participants with Clinically Significant Abnormalities in Physical Examination Under Fasted Condition(Up to 16 days)
- Part 1: Number of Participants with Clinically Significant Abnormalities in Laboratory Safety Tests Under Fed Condition(Up to 23 days)
- Part 1: Number of Participants with Clinically Significant Abnormalities in 12-lead ECGs Under Fasted Condition(Up to 16 days)
- Part 1: Number of Participants with Clinically Significant Abnormalities in 12-lead ECGs Under Fed Condition(Up to 23 days)