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NCT05386758 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate Molnupiravir (MK-4482; MOV) in Participants With Severe Renal Impairment (MK-4482-003)
A Phase 1 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT05386758: Completed Phase 1 study, sponsored by Merck Sharp & Dohme.
NCT05386758 is a Phase 1 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05386758, a Phase 1 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
This purpose of this study is to evaluate the plasma pharmacokinetics (PK) of N-hydroxycytidine (NHC), the nucleoside metabolite of molnupiravir, after a single oral dose of 800 mg molnupiravir in participants with severe renal impairment compared to healthy mean matched control participants. This study will also assess the safety and tolerability of molnupiravir in participants with severe renal impairment and the urinary excretion of NHC after a single oral dose of 800 mg molnupiravir in participants with severe renal impairment compared to healthy mean matched control participants. The primary hypothesis is that the plasma PK participants with severe renal impairment will be similar to that observed in the healthy mean matched control participants.
Primary Outcome
Blood for plasma samples was collected at pre-specified time points to determine the AUC0-inf of NHC.
Interventions
- DRUG Molnupiravir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2022-06-29 |
| Est. Completion | 2023-03-01 |
| Phase | Phase 1 |
What the finished NCT05386758 record still lists
NCT05386758 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 1 intervention - of which Molnupiravir is the first listed.
NCT05386758 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05386758 about?
NCT05386758 is a clinical study titled "A Study to Evaluate Molnupiravir (MK-4482; MOV) in Participants With Severe Renal Impairment (MK-4482-003)". This purpose of this study is to evaluate the plasma pharmacokinetics (PK) of N-hydroxycytidine (NHC), the nucleoside metabolite of molnupiravir, after a single oral dose of 800 mg molnupiravir in participants with severe renal impairment compared to healthy mean matched control participants. This s...
What is the current status of trial NCT05386758?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2022-06-29. Estimated completion is 2023-03-01.
What interventions are being tested in trial NCT05386758?
The interventions under investigation include: Molnupiravir (DRUG).
Who is sponsoring clinical trial NCT05386758?
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 NCT05386758's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 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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