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

January 15, 2025 updated by: Merck Sharp & Dohme LLC

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Hallandale Beach, Florida, United States, 33009
        • Velocity Clinical Research, Hallandale Beach ( Site 0005)
      • Miami, Florida, United States, 33147
        • Advanced Pharma CR, LLC ( Site 0004)
      • Tampa, Florida, United States, 33603
        • Genesis Clinical Research, LLC ( Site 0003)
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University-Pharmacology, Physiology and Cancer Biology ( Site 0001)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Panel A - Severe Renal Impairment Group
Participants with severe renal impairment will receive a single oral 800 mg dose of molnupiravir.
Drug: Molnupiravir
Four 200 mg capsules administered orally as a single dose
Other Names:
  • MK-4482; MOV; EIDD-2801
Experimental: Panel B - Healthy Control Group
Participants in the healthy mean matched control group will receive a single oral 800 mg dose of molnupiravir.
Drug: Molnupiravir
Four 200 mg capsules administered orally as a single dose
Other Names:
  • MK-4482; MOV; EIDD-2801

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Curve From Time 0 to Infinity (AUC0-inf) of N-hydroxycytidine (NHC)
Time Frame: Predose, 0.5,1.5, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdose
Blood for plasma samples was collected at pre-specified time points to determine the AUC0-inf of NHC.
Predose, 0.5,1.5, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdose
Maximum Plasma Concentration (Cmax) of NHC
Time Frame: Predose, 0.5,1.5, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdose
Blood for plasma samples was collected at pre-specified time points to determine the Cmax of NHC.
Predose, 0.5,1.5, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdose
Number of Participants Who Experienced an Adverse Event (AE)
Time Frame: Up to Day 15
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE were reported.
Up to Day 15

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of Dose Administered Excreted in Urine (Ae) of N-hydroxycytidine (NHC)
Time Frame: Predose, 4, 8, 12 and 24 hours postdose
Urine was collected at pre-specified time points to determine the amount of dose Administered excreted in urine (Ae) of NHC.
Predose, 4, 8, 12 and 24 hours postdose
Fraction of the Dose Administered Excreted in Urine (Fe) of NHC
Time Frame: Predose, 4, 8, 12 and 24 hours postdose
Urine was collected at pre-specified time points to determine the Fraction of the dose administered excreted in urine (Fe) of NHC.
Predose, 4, 8, 12 and 24 hours postdose
Renal Clearance (CLr) of NHC
Time Frame: Predose, 4, 8, 12 and 24 hours postdose
Urine will be collected at pre-specified time points to determine the Renal Clearance (CLr) of NHC
Predose, 4, 8, 12 and 24 hours postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 29, 2022

Primary Completion (Actual)

February 4, 2023

Study Completion (Actual)

March 1, 2023

Study Registration Dates

First Submitted

May 18, 2022

First Submitted That Met QC Criteria

May 18, 2022

First Posted (Actual)

May 23, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 15, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4482-003
  • MK-4482-003 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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