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A Pharmacokinetic Study to Assess the Effect of Food in Healthy Male Participants Receiving TMC435

Healthy Clinical Trial

Official title:
A Single-dose, Open-label, Randomized, Two-way Crossover Study to Assess the Effect of Food on the Pharmacokinetics of TMC435 in Japanese Healthy Adult Male Subjects

Clinical Trial Summary

The purpose of this study is to investigate the effect of food on the pharmacokinetics (explores what the body does to the drug) and safety of TMC435 in Japanese healthy adult male participants.

Clinical Trial Description

This is an open-label (all people know the identity of the intervention), single-center, 2-way crossover (method used to switch participants from one treatment arm to another in a clinical trial) and randomized (the study drug is assigned by chance) study to assess the effect of food on the pharmacokinetics of TMC435 after a single dose in Japanese healthy adult male participants. The study duration will be of 44 days per participant, which is divided into 3 parts: Screening (from Day -28 to Day -2); Treatment (consists of 2 treatment periods of 5 days each [that is, Day -1 to 4, in-patient period], wherein all participants will receive TMC435 in the respective period, and the period will be separated by washout period of 9 days); and Follow-up (on Day 7 of Period 2). Participants will keep upright position from the time of study drug administration until 4 hours after study drug administration. Participants will not be allowed to ingest meal until 4 hours post-dose. Participants will have standardized lunch and dinner at 4 hours and 10 hours post-dose, respectively. Drinking water will not be allowed from 1 hour before the administration up to 1 hour after administration except for the water served with the study drug and meal. Pharmacokinetics will be assessed in blood samples which will be collected up to 72 hours after administration of study drug. Participants' safety will be monitored throughout the study. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01799603
Study type Interventional
Source Janssen Research & Development, LLC
Contact
Status Completed
Phase Phase 1
Start date May 2012
Completion date July 2012
View Details
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