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 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT02160756
Brief Summary:
The purpose of this study is to evaluate the pharmacokinetics (PK - the study of the way a drug enters and leaves the blood and tissues over time) and relative bioavailability (the extent to which a drug or other substance becomes available to the body) of JNJ-56021927, when administered as 3 tablet formulations (test) compared with JNJ-54781532 softgel capsule formulation (reference) in healthy male participants under fasted conditions at a single dose of 240 milligram (mg).
Detailed Description:
This is a randomized (study medication assigned to participants by chance), open-label (all people know the identity of the intervention), single-center, 4-treatment, parallel design (a medical research study comparing the response in two or more groups of participants receiving different interventions) study of a single dose of 240 mg JNJ-56021927. The duration of study will be approximately of 78 days per participant. The study consists of 3 parts: Screening phase (that is, 21 days before study commences on Day 1); Open-label Treatment phase (consists of 4 parallel single-dose treatments); and End-of-Study (completion of the Hour 1344 PK sampling on Day 57, or upon early withdrawal). All the eligible participants will be randomly assigned to 1 of the 4 possible treatments: Treatment A (240 mg dose as softgel capsule); Treatment B (240 mg dose as Tablet Formulation 1); Treatment C (240 mg dose as Tablet Formulation 2); or Treatment D (240 mg dose as Tablet Formulation 3). Participants will fast overnight from food and fluids (excluding non-carbonated water) for at least 10 hours before study drug administration on Day 1. Blood samples will be collected pre-dose and over 1,344 hours (Day 57) after dosing for the determination of JNJ-56021927 concentration and its active metabolite. Relative bioavailability of 3 tablet formulations as compared to the softgel capsule formulation of JNJ-56021927 will be evaluated primarily. Participants' safety will be monitored throughout the study.
Study:
NCT02160756
Study Brief:
Protocol Section:
NCT02160756