At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 24 enrolled
Drug / intervention
MK-4250drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single-Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics, and Anti-Retroviral Activity of MK-4250 Monotherapy in Anti-Retroviral Therapy (ART)-Naive, HIV-1 Infected Subjects
In Brief
A Phase 1 clinical trial evaluating MK-4250 for HIV-1 Infection. Completed, enrolled 24 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1 Infection
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedNov 2017
Enrollment StartJan 2018
Primary CompletionNov 2018
TodayJul 2026
First PostedNov 24, 2017
Enrollment StartJan 18, 2018
Primary CompletionNov 2, 2018
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 8.6 years ago
Interventions
MK-4250drug
MK-4250 tablets for oral administration