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Nucleoside Analog

A Study to Evaluate Molnupiravir (MK-4482; MOV) in Participants With Severe Renal Impairment (MK-4482-003)

Phase 1
Waitlist Available
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose, 0.5,1.5, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdose
Awards & highlights
No Placebo-Only Group

Summary

This trial will study the effects of a single dose of molnupiravir on people with severe renal impairment, comparing them to a control group of healthy people. The trial will also assess the safety and tolerability of molnupiravir in participants with severe renal impairment and study the urinary excretion of N-hydroxycytidine (a metabolite of molnupiravir) in participants with severe renal impairment compared to the control group.

Eligible Conditions
  • Kidney Failure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose, 0.5,1.5, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdose
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose, 0.5,1.5, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Area Under the Curve From Time 0 to Infinity (AUC0-inf) of N-hydroxycytidine (NHC)
Maximum Plasma Concentration (Cmax) of NHC
Number of Participants Who Experienced an Adverse Event (AE)
Secondary study objectives
Amount of Dose Administered Excreted in Urine (Ae) of N-hydroxycytidine (NHC)
Fraction of the Dose Administered Excreted in Urine (Fe) of NHC
Renal Clearance (CLr) of NHC

Side effects data

From 2022 Phase 2 & 3 trial • 1735 Patients • NCT04575597
4%
Diarrhoea
4%
COVID-19
1%
COVID-19 pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 1: MK-4482 200 mg
Part 1: MK-4482 400 mg
Part 1: MK-4482 800 mg
Part 1: Placebo
Part 2: MK-4482 800 mg
Part 2: Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Panel B - Healthy Control GroupExperimental Treatment1 Intervention
Participants in the healthy mean matched control group will receive a single oral 800 mg dose of molnupiravir.
Group II: Panel A - Severe Renal Impairment GroupExperimental Treatment1 Intervention
Participants with severe renal impairment will receive a single oral 800 mg dose of molnupiravir.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Molnupiravir
2022
Completed Phase 3
~4590

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
4,027 Previous Clinical Trials
5,188,763 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,900 Previous Clinical Trials
8,090,418 Total Patients Enrolled
~5 spots leftby Dec 2025
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