Study

Overview

Official Title: 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.

Study Type:

Interventional

Study Phase:

Phase 1

Enrollment:

16

Study Start Date:

June 2022

Study Completion Date:

March 2023

Primary Completion Date:

February 2023

Eligibility

Ages Eligible for Study:

18 years to 75 years

Genders Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

CRITERIA

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

Locations

No Contacts or Locations in US/Canada Provided

Results

Click here to access ClinicalTrials.gov site to view results.

Clinical Study Reports

Synopsis MK-4482-003

Study Detail

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

Overview

Eligibility

CRITERIA

Locations

Results