A Study of JNJ-68179280 in Healthy Participants
- Registration Number
- NCT04844463
- Lead Sponsor
- Janssen Research & Development, LLC
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 94
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1: Single Ascending Dose (SAD) JNJ-68179280 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. Part 1: Single Ascending Dose (SAD) Placebo 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. Part 2: Multiple Ascending Dose (MAD) JNJ-68179280 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. Part 2: Multiple Ascending Dose (MAD) Placebo 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. Part 3: Multiple Dose Alternative Formulation (Optional) JNJ-68179280 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.
- Primary Outcome Measures
Name Time Method Number of Participants with Treatment-emergent Adverse Events (TEAEs) 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 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 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) 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 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) Up to 28 days Number of participants with clinically significant abnormalities in ECGs will be reported.
- Secondary Outcome Measures
Name Time Method Part 1, 2 and 3: Plasma Concentration of JNJ-68179280 Up to 19 days Plasma concentration of JNJ-68179280 will be reported.
Part 1: Stool Concentration of JNJ-68179280 Under Fasted Condition Up to Day 6 Stool samples will be analyzed to determine the concentration of JNJ-68179280 under fasted condition.
Part 1: Number of Participants with TEAEs Under Fasted Condition Up to 16 days An 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.
Part 1: Number of Participants with TEAEs Under Fed Condition Up to 23 days An 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.
Part 1: Number of Participants with Clinically Significant Abnormalities in Laboratory Safety Tests Under Fasted Condition Up to 16 days Number of participants with clinically significant abnormalities in laboratory safety tests (such as serum chemistry, hematology and urinalysis) under fasted condition will be reported.
Part 1: Number of Participants with SAEs Under Fasted Condition Up to 16 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.
Part 1: Number of Participants with SAEs Under Fed Condition Up to 23 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.
Part 1: Number of Participants with Clinically Significant Abnormalities in Vital Signs Under Fasted Condition Up to 16 days Number of participants with clinically significant abnormalities in vital signs (including temperature \[oral or tympanic\], pulse/heart rate, respiratory rate, and blood pressure) under fasted condition will be reported.
Part 1, 2 and 3: Urine Concentration of JNJ-68179280 Up to 19 days Urine samples will be analyzed to determine the concentration of JNJ-68179280.
Part 1, 2 and 3: Stool Concentration of JNJ-68179280 Up to 16 days Stool samples will be analyzed to determine the concentration of JNJ-68179280.
Part 1: Plasma Concentration of JNJ-68179280 Under Fasted Condition Up to Day 6 Plasma concentration of JNJ-68179280 under fasted condition will be reported.
Part 1: Plasma Concentration of JNJ-68179280 Under Fed Condition Up to 13 days Plasma concentration of JNJ-68179280 under fed condition will be reported.
Part 1: Stool Concentration of JNJ-68179280 Under Fed Condition Up to 13 days Stool samples will be analyzed to determine the concentration of JNJ-68179280 under fed conditions.
Part 1: Number of Participants with Clinically Significant Abnormalities in Physical Examination Under Fed Condition Up to 23 days Number of participants with clinically significant abnormalities in physical examination (including general appearance, respiratory, cardiovascular, assessment through skin or oral mucosa) under fed condition will be reported.
Part 1: Number of Participants with Clinically Significant Abnormalities in Vital Signs Under Fed Condition Up to 23 days Number of participants with clinically significant abnormalities in vital signs (including temperature \[oral or tympanic\], pulse/heart rate, respiratory rate, and blood pressure) under fed condition will be reported.
Part 1: Number of Participants with Clinically Significant Abnormalities in Physical Examination Under Fasted Condition Up to 16 days Number of participants with clinically significant abnormalities in physical examination (including general appearance, respiratory, cardiovascular, assessment through skin or oral mucosa) under fasted condition will be reported.
Part 1: Number of Participants with Clinically Significant Abnormalities in Laboratory Safety Tests Under Fed Condition Up to 23 days Number of participants with clinically significant abnormalities in laboratory safety tests (such as serum chemistry, hematology and urinalysis) under fed condition will be reported.
Part 1: Number of Participants with Clinically Significant Abnormalities in 12-lead ECGs Under Fasted Condition Up to 16 days Number of participants with clinically significant abnormalities in ECGs under fasted condition will be reported.
Part 1: Number of Participants with Clinically Significant Abnormalities in 12-lead ECGs Under Fed Condition Up to 23 days Number of participants with clinically significant abnormalities in ECGs under fed condition will be reported.
Trial Locations
- Locations (1)
Celerion
🇺🇸Lincoln, Nebraska, United States