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History of Changes for Study: NCT05386758
A Study to Evaluate Molnupiravir (MK-4482; MOV) in Participants With Severe Renal Impairment (MK-4482-003)
Latest version (submitted November 3, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 18, 2022 None (earliest Version on record)
2 June 6, 2022 Study Status and Oversight
3 June 24, 2022 Recruitment Status, Study Status and Contacts/Locations
4 June 29, 2022 Contacts/Locations and Study Status
5 July 15, 2022 Study Status
6 August 8, 2022 Study Status
7 September 2, 2022 Study Status and Contacts/Locations
8 September 9, 2022 Contacts/Locations and Study Status
9 September 15, 2022 Study Status
10 October 10, 2022 Study Status and Contacts/Locations
11 October 13, 2022 Study Status
12 November 3, 2022 Study Status and Eligibility
Comparison Format:

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Study NCT05386758
Submitted Date:  May 18, 2022 (v1)

Open or close this module Study Identification
Unique Protocol ID: 4482-003
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
Secondary IDs: MK-4482-003 [Merck]
Open or close this module Study Status
Record Verification: May 2022
Overall Status: Not yet recruiting
Study Start: June 10, 2022
Primary Completion: November 7, 2022 [Anticipated]
Study Completion: November 18, 2022 [Anticipated]
First Submitted: May 18, 2022
First Submitted that
Met QC Criteria:
May 18, 2022
First Posted: May 23, 2022 [Actual]
Last Update Submitted that
Met QC Criteria:
May 18, 2022
Last Update Posted: May 23, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Merck Sharp & Dohme LLC
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module 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.
Detailed Description:
Open or close this module Conditions
Conditions: Renal Impairment
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 18 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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 Names:
  • 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 Names:
  • MK-4482; MOV; EIDD-2801
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 75 Years
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Study Officials: Medical Director
Study Director
Merck Sharp & Dohme LLC
Locations:
Open or close this module IPDSharing
Plan to Share IPD: Yes
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Supporting Information:
Time Frame:
Access Criteria:
URL: http://engagezone.msd.com/ds_documentation.php
Open or close this module References
Citations:
Links:
Available IPD/Information:

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