A Single-Dose Pharmacokinetics and Safety Study of TMC278 in Healthy Adult Japanese Participants
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|ClinicalTrials.gov Identifier: NCT01804244|
Recruitment Status : Completed
First Posted : March 5, 2013
Last Update Posted : March 19, 2014
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: TMC278||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Single-dose Study to Investigate the Pharmacokinetics and Safety of TMC278 After Oral Administration of TMC278 25 mg Tablet Under Fed Condition in Healthy Japanese Adult Male Subjects|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
All participants will receive a single-dose of TMC278 (1 25-mg tablet [27.5 mg as the hydrochloride salt]) after an overnight fast (going without food) of at least 10 hours before eating a standard breakfast. Study drug will be taken within 10 minutes after completion of a standardized breakfast.
1 25-mg tablet [27.5 mg as the hydrochloride salt) taken orally (by mouth) within 10 minutes after completion of a standardized breakfast on Day 1.
- plasma TMC278 concentrations [ Time Frame: Baseline (predose) up to 168 hours postdose ]Blood samples will be taken at 16 timepoints: Predose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 16, 24, 48, 72, 120, and 168 hours postdose.
- The number of participants who experience adverse events [ Time Frame: Up to 17 days following study drug administration ]As a measure of safety and tolerability
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01804244
|Study Director:||Janssen Pharmaceutical K.K., Japan Clinical Trial||Janssen Pharmaceutical K.K.|