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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
This is a study to evaluate the effect of TMC278 25 mg daily on the QT/QTc interval (heart conduction and heart rhythm) in healthy volunteers. In a separate panel of healthy volunteers, the effect of efavirenz (EFV) 600 mg daily on the QT/QTc interval will be evaluated.
Details
| Lead sponsor | Tibotec Pharmaceuticals, Ireland |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 120 |
| Start date | 2008-08 |
| Completion | 2009-01 |
Conditions
- Human Volunteers
Interventions
- TMC278; Moxifloxacin; Efavirenz
Primary outcomes
- To evaluate the effect of TMC278 25 mg daily at steady state on the QT/QTc interval in healthy volunteers.