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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 : Not yet recruiting
First Posted : May 23, 2022
Last Update Posted : May 23, 2022
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Tracking Information
First Submitted Date  ICMJE May 18, 2022
First Posted Date  ICMJE May 23, 2022
Last Update Posted Date May 23, 2022
Estimated Study Start Date  ICMJE June 10, 2022
Estimated Primary Completion Date November 7, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2022)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2022)
  • 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.
  • 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.
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate Molnupiravir (MK-4482; MOV) in Participants With Severe Renal Impairment (MK-4482-003)
Official Title  ICMJE An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of Molnupiravir (MK-4482; MOV) in Participants With Severe Renal Impairment
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Renal Impairment
Intervention  ICMJE Drug: Molnupiravir
Four 200 mg capsules administered orally as a single dose
Other Name: MK-4482; MOV; EIDD-2801
Study Arms  ICMJE
  • Experimental: Panel A - Severe Renal Impairment Group
    Participants with severe renal impairment will receive a single oral 800 mg dose of molnupiravir.
    Intervention: Drug: Molnupiravir
  • Experimental: Panel B - Healthy Control Group
    Participants in the healthy mean matched control group will receive a single oral 800 mg dose of molnupiravir.
    Intervention: Drug: Molnupiravir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 18, 2022)
18
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 18, 2022
Estimated Primary Completion Date November 7, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05386758
Other Study ID Numbers  ICMJE 4482-003
MK-4482-003 ( Other Identifier: Merck )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Current Responsible Party Merck Sharp & Dohme LLC
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Merck Sharp & Dohme LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme LLC
PRS Account Merck Sharp & Dohme LLC
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP