TMC278-TiDP6-C152: A Study to Assess the Effects of TMC278 and Efavirenz (EFV) on the QT/QTc Interval (Heart Conduction and Heart Rhythm) in Healthy Volunteers.
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|ClinicalTrials.gov Identifier: NCT00744809|
Recruitment Status : Completed
First Posted : September 1, 2008
Last Update Posted : June 9, 2011
|Condition or disease||Intervention/treatment||Phase|
|Human Volunteers||Drug: TMC278; Moxifloxacin; Efavirenz||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||A Phase I, Double-blind, Double-dummy, Randomized, Placebo Controlled and Active Controlled Trial to Evaluate the Effect of TMC278 25 mg Daily at Steady-state and the Effect of Efavirenz (EFV) 600 mg Daily at Steady-state on the QT/QTc Interval, in 2 Randomized Panels of Healthy Volunteers|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||January 2009|
- To evaluate the effect of TMC278 25 mg daily at steady state on the QT/QTc interval in healthy volunteers.
- To evaluate steady-state PK of TMC278 25 mg daily in healthy volunteers; to evaluate the effect of EFV 600 mg daily and separately, a single dose of moxifloxican (400 mg) at steady state, on the QT/QTc interval in healthy volunteers
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): NCT00744809
|Study Director:||Tibotec Pharmaceuticals Clinical Trial||Tibotec Pharmaceutical Limited|