Trials / Completed
CompletedNCT04515641
Single-Dose Islatravir in Moderate Hepatic Impairment (MK-8591-030)
An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of Islatravir (MK-8591) in Participants With Moderate Hepatic Impairment
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Islatravir | Two ISL 30 mg capsules taken by mouth. |
Timeline
- Start date
- 2020-11-05
- Primary completion
- 2021-09-13
- Completion
- 2021-09-13
- First posted
- 2020-08-17
- Last updated
- 2025-07-17
- Results posted
- 2023-07-03
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04515641. Inclusion in this directory is not an endorsement.