A Study of JNJ-68179280 in Healthy Participants

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

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).

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: JNJ-68179280; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: JNJ-68179280; JNJ-68179280 will be administered as an oral capsule.; Other: Placebo; Matching placebo will be administered as an oral capsule.
Experimental: 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.	Drug: JNJ-68179280; JNJ-68179280 will be administered as an oral capsule.; Other: Placebo; Matching placebo will be administered as an oral capsule.
Experimental: 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.	Drug: JNJ-68179280; JNJ-68179280 will be administered as an oral capsule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Treatment-emergent Adverse Events (TEAEs)	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.	Up to 35 days
Number of Participants with Treatment-emergent Serious Adverse Events (SAEs)	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.	Up to 35 days
Number of Participants with Clinically Significant Abnormalities in Vital Signs	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.	Up to 35 days
Number of Participants with Clinically Significant Abnormalities in Physical Examination	Number of participants with clinically significant abnormalities in physical examination (including general appearance, respiratory, cardiovascular, assessment through skin or oral mucosa) will be reported.	Up to 35 days
Number of Participants with Clinically Significant Abnormalities in Laboratory Safety Tests	Number of participants with clinically significant abnormalities in laboratory safety tests (such as serum chemistry, hematology and urinalysis) will be reported.	Up to 35 days
Number of Participants with Clinically Significant Abnormalities in 12-lead Electrocardiograms (ECGs)	Number of participants with clinically significant abnormalities in ECGs will be reported.	Up to 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1, 2 and 3: Plasma Concentration of JNJ-68179280	Plasma concentration of JNJ-68179280 will be reported.	Up to 19 days
Part 1, 2 and 3: Urine Concentration of JNJ-68179280	Urine samples will be analyzed to determine the concentration of JNJ-68179280.	Up to 19 days
Part 1, 2 and 3: Stool Concentration of JNJ-68179280	Stool samples will be analyzed to determine the concentration of JNJ-68179280.	Up to 16 days
Part 1: Plasma Concentration of JNJ-68179280 Under Fasted Condition	Plasma concentration of JNJ-68179280 under fasted condition will be reported.	Up to Day 6
Part 1: Plasma Concentration of JNJ-68179280 Under Fed Condition	Plasma concentration of JNJ-68179280 under fed condition will be reported.	Up to 13 days
Part 1: Stool Concentration of JNJ-68179280 Under Fasted Condition	Stool samples will be analyzed to determine the concentration of JNJ-68179280 under fasted condition.	Up to Day 6
Part 1: Stool Concentration of JNJ-68179280 Under Fed Condition	Stool samples will be analyzed to determine the concentration of JNJ-68179280 under fed conditions.	Up to 13 days
Part 1: Number of Participants with TEAEs Under Fasted Condition	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.	Up to 16 days
Part 1: Number of Participants with TEAEs Under Fed Condition	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.	Up to 23 days
Part 1: Number of Participants with SAEs Under Fasted Condition	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.	Up to 16 days
Part 1: Number of Participants with SAEs Under Fed Condition	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.	Up to 23 days
Part 1: Number of Participants with Clinically Significant Abnormalities in Vital Signs Under Fasted Condition	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.	Up to 16 days
Part 1: Number of Participants with Clinically Significant Abnormalities in Vital Signs Under Fed Condition	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.	Up to 23 days
Part 1: Number of Participants with Clinically Significant Abnormalities in Physical Examination Under Fasted Condition	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.	Up to 16 days
Part 1: Number of Participants with Clinically Significant Abnormalities in Physical Examination Under Fed Condition	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.	Up to 23 days
Part 1: Number of Participants with Clinically Significant Abnormalities in Laboratory Safety Tests Under Fasted Condition	Number of participants with clinically significant abnormalities in laboratory safety tests (such as serum chemistry, hematology and urinalysis) under fasted condition will be reported.	Up to 16 days
Part 1: Number of Participants with Clinically Significant Abnormalities in Laboratory Safety Tests Under Fed Condition	Number of participants with clinically significant abnormalities in laboratory safety tests (such as serum chemistry, hematology and urinalysis) under fed condition will be reported.	Up to 23 days
Part 1: Number of Participants with Clinically Significant Abnormalities in 12-lead ECGs Under Fasted Condition	Number of participants with clinically significant abnormalities in ECGs under fasted condition will be reported.	Up to 16 days
Part 1: Number of Participants with Clinically Significant Abnormalities in 12-lead ECGs Under Fed Condition	Number of participants with clinically significant abnormalities in ECGs under fed condition will be reported.	Up to 23 days

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2021
• Primary Completion (Actual): March 7, 2023
• Study Completion (Actual): March 13, 2023

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 14, 2021

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 21, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CR108989; 68179280IBD1001 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No