Trials / Completed
CompletedNCT05386589
A Study to Evaluate Molnupiravir (MK-4482) in Participants With Moderate Hepatic Impairment (MK-4482-016)
An Open-Label, Single-Dose Clinical Study to Evaluate the Pharmacokinetics of Molnupiravir (MK-4482) in Participants With Moderate Hepatic Impairment
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to evaluate the pharmacokinetics (PK) of N-hydroxycytidine (NHC) following a single oral dose of molnupiravir in participants 18 to 75 years (inclusive) with moderate hepatic impairment and healthy matched controls.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Molnupiravir | Four 200 mg capsules administered orally as a single dose |
Timeline
- Start date
- 2022-06-14
- Primary completion
- 2022-12-18
- Completion
- 2023-01-05
- First posted
- 2022-05-23
- Last updated
- 2025-01-28
- Results posted
- 2024-05-09
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05386589. Inclusion in this directory is not an endorsement.