CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
Doravirinedrug
Likely dose
Doravirine 100 mgfrom 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/NCT02089659
NCT02089659Phase 1Completed
CompareCT.gov

A 2-Part, Open-Label, Singe-Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of MK-1439

Merck Sharp & Dohme LLC·interventional·Posted Mar 18, 2014·Updated Dec 28, 2018

In Brief

A Phase 1 clinical trial evaluating Doravirine for HIV-1 Infection. Completed, enrolled 16 participants.

Detailed Summary

This study aimed to investigate the influence of hepatic insufficiency on the pharmacokinetics (PK) of doravirine (MK-1439). In Part 1, PK of doravirine in participants with moderate hepatic insufficiency was compared with that of healthy control subjects matched with regard to mean age and weight. If a clinically meaningful increase in exposure of doravirine was observed in participants with moderate hepatic insufficiency in Part 1, study Part 2 was to evaluate PK of doravirine in participants with mild hepatic insufficiency.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1 Infection
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 18, 2014
Enrollment StartMar 26, 2014
Primary CompletionMay 12, 2014
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 12.3 years ago

Interventions

Doravirinedrug

Following an overnight fast, a single tablet of 100 mg doravirine was be administered orally