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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: Molnupiravir

Study type: Interventional

Funder types: Industry

Identifiers

NCT05386758

MK-4482-003 (Other Identifier)

4482-003

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Panel A - Severe Renal Impairment Group

Experimental group

Description:

Participants with severe renal impairment will receive a single oral 800 mg dose of molnupiravir.

Treatment:

Drug: Molnupiravir

Panel B - Healthy Control Group

Experimental group

Description:

Participants in the healthy mean matched control group will receive a single oral 800 mg dose of molnupiravir.

Treatment:

Drug: Molnupiravir