drugset / Trial / NCT03351699

Single-Dose Study of MK-4250 Monotherapy in Anti-Retroviral Therapy-Naive, Human Immunodeficiency Virus (HIV)-1 Infected Participants (MK-4250-002)

NCT03351699 ↗

Phase 1 Completed 24 enrolled Merck Sharp & Dohme LLC
Non-randomizedSequentialOpen-labelTreatment

Summary

The study will evaluate the safety, tolerability, pharmacokinetics, and anti-retroviral activity of MK-4250 monotherapy in anti-retroviral therapy (ART)-naïve, HIV-1 infected participants. The primary hypothesis of the study is that at a dose that is sufficiently safe and generally well tolerated, MK-4250 has superior antiretroviral activity compared to a historical placebo, as measured by change from baseline in plasma HIV-1 ribonucleic acid (RNA) (log10 copies/mL) at 168 hours postdose.

Timeline

Start
2018-01-18
Primary completion
2018-11-02
Completion
2018-11-02

Drugs

EvaluationDrugModalityDoseRoute
Subject MK-4250 Unknown 150 mg Oral
Subject MK-4250 Unknown 600 mg Oral
Subject MK-4250 Unknown 900 mg Oral