Molnupiravir for Kidney Failure

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Genesis Clinical Research, LLC ( Site 0003), Tampa, FL
Kidney Failure+1 More
Molnupiravir - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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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.

Eligible Conditions

  • Kidney Failure
  • deteriorating renal function

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Kidney Failure

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: At designated time points (Up to 72 hours)

Hour 24
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
Hour 72
Area Under the Curve From Time 0 to Infinity (AUC0-inf) of N-hydroxycytidine (NHC)
Maximum Plasma Concentration (Cmax) of NHC
Day 14
Number of Participants who Experienced an Adverse Event (AE)

Trial Safety

Safety Progress

1 of 3

Other trials for Kidney Failure

Trial Design

2 Treatment Groups

Panel B - Healthy Control Group
1 of 2
Panel A - Severe Renal Impairment Group
1 of 2
Experimental Treatment

18 Total Participants · 2 Treatment Groups

Primary Treatment: Molnupiravir · No Placebo Group · Phase 1

Panel B - Healthy Control Group
Drug
Experimental Group · 1 Intervention: Molnupiravir · Intervention Types: Drug
Panel A - Severe Renal Impairment 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: Genesis Clinical Research, LLC ( Site 0003) · Tampa, FL
Photo of Tampa  1Photo of Tampa  2Photo of Tampa  3
N/AFirst Recorded Clinical Trial
0 TrialsResearching Kidney Failure
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a body mass index (BMI) of 18.5 or greater and less than 35 kilograms per square meter.

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.