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

NCT05386758 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 4482-003MK-4482-003
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 4

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 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.

Conditions

Renal Impairment

Outcome Measures

Primary Outcomes (3)

• Area Under the Curve From Time 0 to Infinity (AUC0-inf) of N-hydroxycytidine (NHC)

  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

  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)

  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 Outcomes (3)

• Amount of Dose Administered Excreted in Urine (Ae) of N-hydroxycytidine (NHC)

  Predose, 4, 8, 12 and 24 hours postdose

• Fraction of the Dose Administered Excreted in Urine (Fe) of NHC

  Predose, 4, 8, 12 and 24 hours postdose

• Renal Clearance (CLr) of NHC

  Predose, 4, 8, 12 and 24 hours postdose

Study Arms (2)

Panel A - Severe Renal Impairment Group

EXPERIMENTAL

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

Drug: Molnupiravir

Panel B - Healthy Control Group

EXPERIMENTAL

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

Drug: Molnupiravir

Interventions

Molnupiravir DRUG

Four 200 mg capsules administered orally as a single dose

Also known as: MK-4482; MOV; EIDD-2801

Panel A - Severe Renal Impairment Group; Panel B - Healthy Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (4)

Velocity Clinical Research, Hallandale Beach ( Site 0005)

Hallandale, Florida, 33009, United States

Location

Advanced Pharma CR, LLC ( Site 0004)

Miami, Florida, 33147, United States

Location

Genesis Clinical Research, LLC ( Site 0003)

Tampa, Florida, 33603, United States

Location

Thomas Jefferson University-Pharmacology, Physiology and Cancer Biology ( Site 0001)

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

• Duncan KE, Carstens RP, Butterfield KL, Jin Y, Inbody LR, Schaeffer AK, Matthews CZ, Zhao T, Patel S, Maas BM, Cheng MH, Stoch SA. Assessment of pharmacokinetics and tolerability following single-dose administration of molnupiravir in participants with hepatic or renal impairment. Clin Transl Sci. 2024 Dec;17(12):e70073. doi: 10.1111/cts.70073.

  PMID: 39601078 RESULT

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Renal Insufficiency

Interventions

molnupiravir

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 23, 2022
• Study Start: June 29, 2022
• Primary Completion: February 4, 2023
• Study Completion: March 1, 2023
• Last Updated: January 28, 2025
• Results First Posted: July 5, 2024

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

US (4)