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)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MK-4250 | Unknown | 150 mg | Oral |
| Subject | MK-4250 | Unknown | 600 mg | Oral |
| Subject | MK-4250 | Unknown | 900 mg | Oral |