CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
MK-8504drug
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.

Search/NCT03188523
NCT03188523Phase 1Completed
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A Single-Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics, and Anti-Retroviral Activity of MK-8504 Monotherapy in Anti-Retroviral Therapy (ART)-Naïve, HIV-1 Infected Patients

Merck Sharp & Dohme LLC·interventional·Posted Jun 15, 2017·Updated Jul 15, 2019

In Brief

A Phase 1 clinical trial evaluating MK-8504 for HIV-1 Infection. Completed, enrolled 12 participants across 2 sites in 2 countries.

Detailed Summary

This study aims to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-retroviral therapy (ART) activity of monotherapy with MK-8504 (a tenofovir pro-drug), in ART-naïve Human Immunodeficiency Virus (HIV)-1 infected participants. The primary hypothesis is that MK-8504, at a dose that is sufficiently safe and well tolerated, has superior antiretroviral activity compared to placebo, as measured by change from baseline in plasma HIV-1 ribonucleic acid (RNA) at 168 hours post-dose.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1 Infection
CountriesGermany, United Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedJun 15, 2017
Enrollment StartSep 8, 2017
Primary CompletionMay 21, 2018
Study CompletionJun 4, 2018
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 9.0 years ago

Interventions

MK-8504drug

After at least an 8-hour fast, a single oral dose of MK-8504 will be administered in capsule form.