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A Crossover Study to Evaluate the Relative Oral Bioavailability and Food Effect After Single Dose Administration of JNJ-54861911 Tablet in Healthy Elderly Participants

Healthy Clinical Trial

Official title:
An Open-Label, Randomized, Three-Period Crossover Study to Evaluate the Relative Oral Bioavailability and Food Effect of JNJ-54861911 Tablet (1x25mg) After Single Dose Administration in Healthy Elderly Subjects

Clinical Trial Summary

The purpose of this study is to assess the effect of a high-fat/high-caloric breakfast on the rate and extent of absorption of the single oral dose of 25 mg JNJ-54861911 test formulation in healthy elderly participants.

Clinical Trial Description

This is a randomized (study medication assigned to participants by chance), open-label (all people know the identity of the intervention), 3-treatment, 3-period, 6-sequence crossover (participants may receive different interventions sequentially during the trial), and single-center study of JNJ-54861911. The duration of study will be approximately of 7 weeks per participant. The study consists of 3 parts: Screening (that is, 21 days before study commences on Day 1); Open-label Treatment (consists of 3 single-dose treatments, either JNJ-54861911 formulation 1 [reference] or JNJ-54861911 formulation 2 [test] under fed or fasted condition), in subsequent 3-treatment periods, each separated with washout period of 7 days); and End-of-Study (up-to 14 days after last study drug administration). All the eligible participants will be randomly assigned to 1 of the 6 treatment sequences. In fasted conditions, study drug will be administered following a 10-hour overnight fast. In fed conditions, participants will also fast from food for 10 hours, but will consume a high fat/high calorie breakfast within a 30-minute period. Study drug will be administered 30 minutes after the start of breakfast. Participants will not be allowed to have food until 4 hours of drug administration. Blood samples will be collected for evaluation of pharmacokinetics at pre-dose and post-dose of study treatment. Relative bioavailability of two formulations of JNJ-54861911 (test and reference) will be evaluated primarily. Participants' safety will be monitored throughout the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02355561
Study type Interventional
Source Janssen Research & Development, LLC
Contact
Status Completed
Phase Phase 1
Start date January 2015
Completion date March 2015
View Details
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