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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 is a Phase 1 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 16 participants.
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.
Interventions
- DRUG Molnupiravir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2022-06-29 |
| Est. Completion | 2023-03-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05386758
The ClinicalTrials.gov registry entry for NCT05386758 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Molnupiravir is the first listed.
NCT05386758 reports 0 study locations.
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.
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