Molnupiravir for Hepatic Impairment

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Clinical Pharmacology of Miami ( Site 0003), Miami, FL
Hepatic Impairment+1 More
Molnupiravir - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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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.

Eligible Conditions

  • Hepatic Impairment

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Hepatic Impairment

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: At designated time points (Up to 72 hours)

Hour 72
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
Day 14
Number of participants experiencing Adverse events (AE)

Trial Safety

Safety Progress

1 of 3

Other trials for Hepatic Impairment

Trial Design

2 Treatment Groups

Moderate Hepatic Impairment
1 of 2
Healthy-Matched Control Group
1 of 2
Experimental Treatment

17 Total Participants · 2 Treatment Groups

Primary Treatment: Molnupiravir · No Placebo Group · Phase 1

Moderate Hepatic Impairment
Drug
Experimental Group · 1 Intervention: Molnupiravir · Intervention Types: Drug
Healthy-Matched Control Group
Drug
Experimental Group · 1 Intervention: Molnupiravir · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Molnupiravir
2020
Completed Phase 3
~1740

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at designated time points (up to 72 hours)
Closest Location: Clinical Pharmacology of Miami ( Site 0003) · Miami, FL
Photo of Miami  1Photo of Miami  2Photo of Miami  3
2021First Recorded Clinical Trial
1 TrialsResearching Hepatic Impairment
1 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.