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Molnupiravir for Liver Disease

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
The key inclusion
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at designated time points (up to 72 hours)
Awards & highlights

Study Summary

This trial will study the effects of a single dose of molnupiravir on N-hydroxycytidine levels in people with moderate hepatic impairment and healthy controls.

Eligible Conditions
  • Liver Disease

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at designated time points (up to 72 hours)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at designated time points (up to 72 hours) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Plasma N-Hydroxycitidine (NHC)
Maximum Plasma Concentration (Cmax) of NHC
Secondary outcome measures
Number of participants experiencing Adverse events (AE)

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

Trial Design

2Treatment groups
Experimental Treatment
Group I: Moderate Hepatic ImpairmentExperimental Treatment1 Intervention
Participants with moderate hepatic impairment will receive a single oral 800mg dose of molnupiravir.
Group II: Healthy-Matched Control GroupExperimental Treatment1 Intervention
Healthy matched participants will receive a single oral 800mg dose of molnupiravir.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Molnupiravir
2022
Completed Phase 3
~4360

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
3,886 Previous Clinical Trials
5,054,539 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,472 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are eligible for this clinical experiment?

"Affirmative. Clinicaltrials.gov details indicate that the trial, which was first published on June 14th 2022, is currently recruiting participants. Specifically, 17 patients are being sought from 3 clinical sites."

Answered by AI

Is the recruitment phase of this experiment still open to participants?

"Correct. Clinicaltrials.gov's information affirms that the trial, initially published on June 14th 2022, is actively seeking enrolment. A total of 17 patients need to be enrolled from 3 distinct healthcare locations."

Answered by AI

Are there any concerning safety profiles associated with Molnupiravir consumption?

"Due to the nascent nature of this drug's clinical trials, Molnupiravir is given a safety score of 1. This rating reflects its limited data backing both efficacy and security."

Answered by AI

Is it possible to participate in this clinical investigation?

"This trial seeks 17 individuals between ages 18 and 75 who suffer from hepatic impairment. To qualify, applicants must meet the following criteria: The key inclusion."

Answered by AI

Are seniors above the age of 60 accepted for participation in this experiment?

"Individuals that fulfil the criteria for this medical trial must be over 18 years of age and below 75."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate Molnupiravir (MK-4482) in Participants With Moderate Hepatic Impairment (MK-4482-016)
2022. "A Study to Evaluate Molnupiravir (MK-4482) in Participants With Moderate Hepatic Impairment (MK-4482-016)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05386589.
~5 spots leftby Apr 2025
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