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

Completed · Phase 1

Conditions studied: Renal Impairment

In brief

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.

Key facts

Study ID

NCT05386758

Run by

Merck Sharp & Dohme LLC

People needed

16

Starts

2022-06-29

Expected to finish

2023-03-01

Last updated by the study team

2025-01-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• The key Inclusion Criteria include but are not limited to the following:
• Body mass index (BMI) ≥18.5 kg/m\^2 and ≤35 kg/m\^2
• Healthy participants: Baseline estimated glomerular filtration rate (eGFR) ≥90 mL/min based on the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine equation
• Severe renal impairment participants: Baseline estimated glomerular filtration rate (eGFR) <30 mL/min based on the 2021 CKD-EPI Creatinine equation

You may not qualify if…

• The key Exclusion Criteria include but are not limited to the following:
• Positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV)
• History of major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit
• Severe renal impairment participants:
• History or presence of renal artery stenosis
• Had a renal transplant
• Currently taking medications to treat chronic medical conditions associated with renal disease if participant has not been on a stable regimen for at least 1 month and/or is unable to withhold the use of medication(s) within 4 hours prior to and 8 hours after administration of the study drug

Where it is running

• 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

Full record on ClinicalTrials.gov

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