At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 12 enrolled
Drug / intervention
Islatravirdrug
Likely dose
Islatravir 30 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.
An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of Islatravir (MK-8591) in Participants With Moderate Hepatic Impairment
In Brief
A Phase 1 clinical trial evaluating Islatravir for Human Immunodeficiency Virus (HIV) Infection. Completed, enrolled 12 participants across 1 site.
Detailed Summary
This is an open-label, single-dose study of the plasma pharmacokinetics (PK), safety, and tolerability of islatravir (ISL, MK-8591), and the intracellular PK of ISL triphosphate (ISL-TP) in male and female adult participants with moderate hepatic impairment and in healthy matched control participants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
202120222023202420252026
First PostedAug 2020
Enrollment StartNov 2020
Primary CompletionSep 2021
TodayJul 2026
First PostedAug 17, 2020
Enrollment StartNov 5, 2020
Primary CompletionSep 13, 2021
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 5.9 years ago
Interventions
Islatravirdrug
Two ISL 30 mg capsules taken by mouth.