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NCT05386589 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate Molnupiravir (MK-4482) in Participants With Moderate Hepatic Impairment (MK-4482-016)
A Phase 1 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT05386589: Completed Phase 1 study, sponsored by Merck Sharp & Dohme.
NCT05386589 is a Phase 1 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05386589, a Phase 1 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study 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.
Primary Outcome
The plasma AUC0-∞ of NHC is reported.
Interventions
- DRUG Molnupiravir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2022-06-14 |
| Est. Completion | 2023-01-05 |
| Phase | Phase 1 |
What the finished NCT05386589 record still lists
NCT05386589 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which Molnupiravir is the first listed.
NCT05386589 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05386589 about?
NCT05386589 is a clinical study titled "A Study to Evaluate Molnupiravir (MK-4482) in Participants With Moderate Hepatic Impairment (MK-4482-016)". 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.
What is the current status of trial NCT05386589?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2022-06-14. Estimated completion is 2023-01-05.
What interventions are being tested in trial NCT05386589?
The interventions under investigation include: Molnupiravir (DRUG).
Who is sponsoring clinical trial NCT05386589?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05386589's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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