drugset / Trial / NCT01230385

Safety And Tolerability Of Multiple Dose Lersivirine For 21 Days In Healthy Subjects

NCT01230385

Phase 1 Completed 75 enrolled Pfizer ViiV Healthcare · collab
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

EvaluationDrugModalityDoseRoute
Comparator Lersivirine Small molecule 500 mg
Comparator Lersivirine Small molecule 750 mg

Indications

No indication recorded.