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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-29

Study Completion Date

2023-03-01

Brief Summary

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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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Detailed Description

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Conditions

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Renal Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Panel A - Severe Renal Impairment Group

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

Group Type EXPERIMENTAL

Molnupiravir

Intervention Type DRUG

Four 200 mg capsules administered orally as a single dose

Panel B - Healthy Control Group

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

Group Type EXPERIMENTAL

Molnupiravir

Intervention Type DRUG

Four 200 mg capsules administered orally as a single dose

Interventions

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Molnupiravir

Four 200 mg capsules administered orally as a single dose

Intervention Type DRUG

Other Intervention Names

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MK-4482; MOV; EIDD-2801

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes