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Completed

NCT Number: NCT05386758

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

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.

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Key information

Conditions

Renal Impairment Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Velocity Clinical Research, Hallandale Beach ( Site 0005), Hallandale, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Molnupiravir

Drug

Four 200 mg capsules administered orally as a single dose

Other names: MK-4482; MOV; EIDD-2801

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of Molnupiravir (MK-4482; MOV) in Participants With Severe Renal Impairment

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 23, 2022
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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