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

• ClinicalTrials.gov Identifier: NCT05386758
• Recruitment Status: Not yet recruiting
• First Posted: May 23, 2022
• Last Update Posted: May 23, 2022
• Sponsor: Merck Sharp & Dohme LLC
• Information provided by (Responsible Party): Merck Sharp & Dohme LLC

Tracking Information

• First Submitted Date: May 18, 2022
• First Posted Date: May 23, 2022
• Last Update Posted Date: May 23, 2022
• Estimated Study Start Date: June 10, 2022
• Estimated Primary Completion Date: November 7, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Renal Impairment

Intervention

Drug: Molnupiravir

Four 200 mg capsules administered orally as a single dose

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

Study Arms

• 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

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: May 18, 2022): 18
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 18, 2022
• Estimated Primary Completion Date: November 7, 2022 (Final data collection date for primary outcome measure)

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 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

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT05386758
• Other Study ID Numbers: 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

• 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: Merck Sharp & Dohme LLC
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Medical Director; Merck Sharp & Dohme LLC

• PRS Account: Merck Sharp & Dohme LLC
• Verification Date: May 2022