Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:05 PM
Ignite Modification Date:
2025-12-24 @ 2:05 PM
NCT ID:
NCT02670395
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:
NCT02670395
Study Brief:
Protocol Section:
NCT02670395