Trials / Not Yet Recruiting
Not Yet RecruitingNCT05093972
Ulonivirine (MK-8507) in Participants With Mild or Moderate Hepatic Impairment (MK-8507-014)
An Open-Label, Single-Dose Clinical Study to Evaluate Pharmacokinetics of MK-8507 in Participants With Mild or Moderate Hepatic Impairment.
- Status
- Not Yet Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 22 (estimated)
- 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 pharmacokinetics (PK) and safety of a single oral dose of ulonivirine in participants with mild or moderate hepatic impairment (HI). It is hypothesized that the area under the plasma concentration-time curve from dosing to (extrapolated) infinity (AUC0-∞) in participants with mild or moderate HI is similar to that of healthy control participants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ulonivirine | Four ulonivirine 100 mg tablets (total dose 400 mg) taken by mouth. |
Timeline
- Start date
- 2026-04-07
- Primary completion
- 2026-09-10
- Completion
- 2026-09-10
- First posted
- 2021-10-26
- Last updated
- 2025-02-18
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05093972. Inclusion in this directory is not an endorsement.