Status:
COMPLETED
A Study to Evaluate Molnupiravir (MK-4482; MOV) in Participants With Severe Renal Impairment (MK-4482-003)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Renal Impairment
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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 par...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2023
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT05386758
Start Date
June 29 2022
End Date
March 1 2023
Last Update
January 28 2025
Active Locations (4)
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1
Velocity Clinical Research, Hallandale Beach ( Site 0005)
Hallandale, Florida, United States, 33009
2
Advanced Pharma CR, LLC ( Site 0004)
Miami, Florida, United States, 33147
3
Genesis Clinical Research, LLC ( Site 0003)
Tampa, Florida, United States, 33603
4
Thomas Jefferson University-Pharmacology, Physiology and Cancer Biology ( Site 0001)
Philadelphia, Pennsylvania, United States, 19107