Ignite Creation Date:
2025-12-24 @ 2:05 PM
Ignite Modification Date:
2026-02-21 @ 12:30 AM
Study NCT ID:
NCT02670395
Status:
COMPLETED
Last Update Posted:
2025-02-03
First Post:
2016-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Safety, Tolerability, Food Effect, and Pharmacokinetics of JNJ-54416076 in Healthy Participants
Sponsor:
Janssen Research & Development, LLC
Organization:
Study Overview
Official Title:
A Double Blind, Placebo-Controlled, Randomized, Single Ascending Dose Study to Investigate the Safety, Tolerability, Food Effect, and Pharmacokinetics of JNJ-54416076 in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of JNJ-54416076 and any associated metabolite(s) (in Part 1) and safety, tolerability and PK of JNJ-54416076 when co administered with food compared to administration in fasting condition (in Part 2).
Detailed Description:
This is a Phase 1, single-center, first-in-human study consists of 2 parts : a) Single Ascending Dose part and b) PK-Food Effect part. Part 1 is a randomized (the study medication is assigned by chance), double-blind (neither the Investigator nor the participant know the treatment), sequential cohort, single ascending oral dose study. Part 1 will assess the safety, tolerability, and PK of single ascending doses of JNJ-54416076 in healthy male participants. It will consist of 8 cohorts of 8 healthy participants. Within each cohort, 6 participants will be randomly assigned to JNJ-54416076 treatment, and 2 participants will be randomly assigned to placebo treatment. The total study duration for each participant in Part 1 will be up to approximately 5 weeks. Part 2 is a randomized, open-label (all people know the identity of the intervention), 2-period crossover study. Part 2 will assess the effect of food on the pharmacokinetics of JNJ-54416076. Each participant in Part 2 will receive 2 doses of JNJ-54416076 (one dose in the fasted state and an identical dose in the fed state). The dose selected for Part 2 will be selected based on the preliminary safety and PK data in Part 1. The total study duration for each participant in Part 2 will be up to approximately 7 weeks. Participants' safety will be monitored throughout the study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: