drugset / Trial / NCT01230385
Safety And Tolerability Of Multiple Dose Lersivirine For 21 Days In Healthy Subjects
RandomizedParallel-groupOpen-labelTreatment
Summary
Randomized, open-label, parallel group study in a group of 75 healthy subjects, to evaluate the safety and toleration of 2 different doses of lersivirine administered either fed or fasted (proposed Phase 3 formulation) given over 21 days, compared to lersivirine 500 mg QD (Phase 2b formulation). The pharmacokinetics of lersivirine in each group will also be evaluated.
Timeline
- Start
- 2010-10
- Primary completion
- 2011-05
- Completion
- 2011-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Lersivirine | Small molecule | 500 mg | — |
| Comparator | Lersivirine | Small molecule | 750 mg | — |
Indications
No indication recorded.