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 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT02448004
Brief Summary:
The primary objective of this study is to characterize the absorption and metabolic pathways of JNJ-63623872, and the excretion of the compound and its metabolites, after single oral dosing of 14C-JNJ-63623872 in healthy adult male participants.
Detailed Description:
This is a Phase 1, open-label (all people know the identity of the intervention), single dose study in 6 healthy adult male participants to characterize the absorption, metabolism and excretion of 14C-JNJ-63623872. The total study duration will be approximately of 16 days per participant. The study consists of 3 parts: Screening (that is, 28 days before study commences on Day 1); open-Label Treatment Phase(that is, Day 1); and Follow-up (that is, up to Day 16). All the eligible participants will receive 14C-JNJ-63623872 at a dose level of 600 milligram. Participants will enter the study site on Day -1 and stay at the study site at least until Day 8. Urine, feces, whole blood samples, plasma, nasal mucus and saliva samples will be collected up to Day 8. Unchanged JNJ-63623872 will be determined in plasma and, if feasible, in saliva. Participants' safety will be monitored throughout the study.
Study:
NCT02448004
Study Brief:
Protocol Section:
NCT02448004