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An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of Molnupiravir (MK-4482; MOV) in Participants With Severe Renal Impairment
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.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
Yes
Velocity Clinical Research, Hallandale Beach ( Site 0005)
Hallandale, Florida, United States
Advanced Pharma CR, LLC ( Site 0004)
Miami, Florida, United States
Genesis Clinical Research, LLC ( Site 0003)
Tampa, Florida, United States
Thomas Jefferson University-Pharmacology, Physiology and Cancer Biology ( Site 0001)
Philadelphia, Pennsylvania, United States
Start Date
June 29, 2022
Primary Completion Date
February 4, 2023
Completion Date
March 1, 2023
Last Updated
January 28, 2025
16
ACTUAL participants
Molnupiravir
DRUG
Lead Sponsor
Merck Sharp & Dohme LLC
NCT07154901
NCT07165015
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06352411