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

Primary Purpose

Renal Impairment

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Molnupiravir

About this trial

This is an interventional treatment trial for Renal Impairment

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Velocity Clinical Research, Hallandale Beach ( Site 0005)
Advanced Pharma CR, LLC ( Site 0004)
Genesis Clinical Research, LLC ( Site 0003)
Thomas Jefferson University-Pharmacology, Physiology and Cancer Biology ( Site 0001)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Panel A - Severe Renal Impairment Group

Panel B - Healthy Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Blood for plasma samples will be collected at pre-specified time points to determine the AUC0-inf of NHC.

Maximum Plasma Concentration (Cmax) of NHC

Blood for plasma samples will be collected at pre-specified time points to determine the Cmax of NHC.

Secondary Outcome Measures

Number of Participants who Experienced an Adverse Event (AE)

An AE is 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 can therefore be 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 will be reported.

Amount of dose administered excreted in urine (Ae) of N-hydroxycytidine (NHC)

Urine will be collected at pre-specified time points to determine the Ae of NHC.

Fraction of the dose administered excreted in urine (Fe) of NHC

Urine will be collected at pre-specified time points to determine the Fe of NHC.

Renal Clearance (CLr) of NHC

Urine will be collected at pre-specified time points to determine the CLr of NHC

Full Information

NCT ID

NCT05386758

First Posted

May 18, 2022

Last Updated

March 7, 2023

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT05386758

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

June 29, 2022 (Actual)

Primary Completion Date

February 4, 2023 (Actual)

Study Completion Date

March 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Impairment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Panel A - Severe Renal Impairment Group

Arm Type

Experimental

Arm Description

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

Arm Title

Panel B - Healthy Control Group

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Molnupiravir

Other Intervention Name(s)

MK-4482; MOV; EIDD-2801

Intervention Description

Four 200 mg capsules administered orally as a single dose

Primary Outcome Measure Information:

Title

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

Description

Blood for plasma samples will be collected at pre-specified time points to determine the AUC0-inf of NHC.

Time Frame

At designated time points (Up to 72 hours)

Title

Maximum Plasma Concentration (Cmax) of NHC

Description

Blood for plasma samples will be collected at pre-specified time points to determine the Cmax of NHC.

Time Frame

At designated time points (Up to 72 hours)

Secondary Outcome Measure Information:

Title

Number of Participants who Experienced an Adverse Event (AE)

Description

Time Frame

Up to approximately 14 days

Title

Amount of dose administered excreted in urine (Ae) of N-hydroxycytidine (NHC)

Description

Urine will be collected at pre-specified time points to determine the Ae of NHC.

Time Frame

At designated time points (Up to 24 hours)

Title

Fraction of the dose administered excreted in urine (Fe) of NHC

Description

Urine will be collected at pre-specified time points to determine the Fe of NHC.

Time Frame

At designated time points (Up to 24 hours)

Title

Renal Clearance (CLr) of NHC

Description

Urine will be collected at pre-specified time points to determine the CLr of NHC

Time Frame

At designated time points (Up to 24 hours)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

Facility Information:

Facility Name

Velocity Clinical Research, Hallandale Beach ( Site 0005)

City

Hallandale Beach

State/Province

Florida

ZIP/Postal Code

33009

Country

United States

Facility Name

Advanced Pharma CR, LLC ( Site 0004)

City

Miami

State/Province

Florida

ZIP/Postal Code

33147

Country

United States

Facility Name

Genesis Clinical Research, LLC ( Site 0003)

City

Tampa

State/Province

Florida

ZIP/Postal Code

33603

Country

United States

Facility Name

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

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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

IPD Sharing URL

http://engagezone.msd.com/ds_documentation.php

Learn more about this trial

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

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