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Trial record 2 of 16 for:    molnupiravir

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

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ClinicalTrials.gov Identifier: NCT05386758
Recruitment Status : Recruiting
First Posted : May 23, 2022
Last Update Posted : September 16, 2022
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

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.

Condition or disease Intervention/treatment Phase
Renal Impairment Drug: Molnupiravir Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of Molnupiravir (MK-4482; MOV) in Participants With Severe Renal Impairment
Actual Study Start Date : June 29, 2022
Estimated Primary Completion Date : November 7, 2022
Estimated Study Completion Date : November 18, 2022

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 Name: 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 Name: MK-4482; MOV; EIDD-2801




Primary Outcome Measures :
  1. Area Under the Curve From Time 0 to Infinity (AUC0-inf) of N-hydroxycytidine (NHC) [ Time Frame: At designated time points (Up to 72 hours) ]
    Blood for plasma samples will be collected at pre-specified time points to determine the AUC0-inf of NHC.

  2. Maximum Plasma Concentration (Cmax) of NHC [ Time Frame: At designated time points (Up to 72 hours) ]
    Blood for plasma samples will be collected at pre-specified time points to determine the Cmax of NHC.


Secondary Outcome Measures :
  1. Number of Participants who Experienced an Adverse Event (AE) [ Time Frame: Up to approximately 14 days ]
    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.

  2. Amount of dose administered excreted in urine (Ae) of N-hydroxycytidine (NHC) [ Time Frame: At designated time points (Up to 24 hours) ]
    Urine will be collected at pre-specified time points to determine the Ae of NHC.

  3. Fraction of the dose administered excreted in urine (Fe) of NHC [ Time Frame: At designated time points (Up to 24 hours) ]
    Urine will be collected at pre-specified time points to determine the Fe of NHC.

  4. Renal Clearance (CLr) of NHC [ Time Frame: At designated time points (Up to 24 hours) ]
    Urine will be collected at pre-specified time points to determine the CLr of NHC



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 or nephrectomy
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05386758


Contacts
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Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

Locations
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United States, Florida
Velocity Clinical Research, Hallandale Beach ( Site 0005) Recruiting
Hallandale Beach, Florida, United States, 33009
Contact: Study Coordinator    305-206-7179      
Advanced Pharma CR, LLC ( Site 0004) Recruiting
Miami, Florida, United States, 33147
Contact: Study Coordinator    786-863-3320      
Genesis Clinical Research, LLC ( Site 0003) Recruiting
Tampa, Florida, United States, 33603
Contact: Study Coordinator    813-755-4403      
United States, Pennsylvania
Thomas Jefferson University - Pharmacology and Experimental Therapeutics ( Site 0001) Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Study Coordinator    215-955-6084      
Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
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Study Director: Medical Director Merck Sharp & Dohme LLC
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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT05386758    
Other Study ID Numbers: 4482-003
MK-4482-003 ( Other Identifier: Merck )
First Posted: May 23, 2022    Key Record Dates
Last Update Posted: September 16, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases