A Study to Evaluate Molnupiravir Tablet Formulation Compared to the Molnupiravir Capsule Formulation in Healthy Adult Participants (MK-4482-011)

July 8, 2025 updated by: Merck Sharp & Dohme LLC

A Study to Evaluate the Pharmacokinetics and Definitive Bioequivalence of Molnupiravir Tablet Formulation Compared to the Molnupiravir Capsule Formulation in Healthy Adult Participants

The goal of the study is to learn what happens to different forms of molnupiravir (MOV) medications in a healthy person's body over time when taken on an empty stomach or with food. Researchers will compare the amount of MOV in the healthy person's body over time when different forms of medications are given.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • South Miami, Florida, United States, 33143
        • QPS-MRA, LLC-Early Phase (Site 0002)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

- Has body mass index (BMI) ≥18 kg/m^2 and ≤32 kg/m^2.

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

  • History of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
  • History of significant multiple and/or severe allergies (eg, food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (ie, systemic allergic reaction) to prescription or nonprescription drugs or food.
  • Positive test(s) for Hepatitis B surface antigen (HBsAg), hepatitis C antibodies or Human immunodeficiency virus (HIV).
  • History of a major surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Molnupiravir Treatment A
Participants receive molnupiravir reference capsule.
Drug: Molnupiravir
Oral Administration.
Other Names:
  • MK-4482
  • MOV
  • EIDD-2801
  • LAGEVRIO
Experimental: Molnupiravir Treatment B
Participants receive molnupiravir Formulation 1.
Drug: Molnupiravir
Oral Administration.
Other Names:
  • MK-4482
  • MOV
  • EIDD-2801
  • LAGEVRIO
Experimental: Molnupiravir Treatment C
Participants receive molnupiravir Formulation 1 after a high-fat meal.
Drug: Molnupiravir
Oral Administration.
Other Names:
  • MK-4482
  • MOV
  • EIDD-2801
  • LAGEVRIO
Experimental: Molnupiravir Treatment D
Participants receive molnupiravir Formulation 2.
Drug: Molnupiravir
Oral Administration.
Other Names:
  • MK-4482
  • MOV
  • EIDD-2801
  • LAGEVRIO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of N-Hydroxycitidine (NHC) in plasma: Treatment A versus Treatment B
Time Frame: Pre-dose, and at designated timepoints up to 72 hours postdose
AUC0-inf of NHC in plasma will be determined.
Pre-dose, and at designated timepoints up to 72 hours postdose
Area Under the Concentration-Time Curve From Time Zero to last measurable timepoint (AUC0-last) of NHC in plasma: Treatment A versus Treatment B
Time Frame: Pre-dose, and at designated timepoints up to 72 hours postdose
AUC0-last of NHC in plasma will be determined.
Pre-dose, and at designated timepoints up to 72 hours postdose
Area Under the Concentration-Time Curve From Time Zero to 12 hours (AUC0-12) of (NHC) in plasma: Treatment A versus Treatment B
Time Frame: Pre-dose, and at designated timepoints up to 12 hours postdose
AUC0-12 of NHC in plasma will be determined.
Pre-dose, and at designated timepoints up to 12 hours postdose
Maximum plasma concentration (Cmax) of NHC: Treatment A versus Treatment B
Time Frame: Pre-dose, and at designated timepoints up to 72 hours postdose
Cmax of NHC in plasma will be determined.
Pre-dose, and at designated timepoints up to 72 hours postdose
Time to maximum plasma concentration (Tmax) of NHC: Treatment A versus Treatment B
Time Frame: Pre-dose, and at designated timepoints up to 72 hours postdose
Tmax of NHC in plasma will be determined.
Pre-dose, and at designated timepoints up to 72 hours postdose
Apparent terminal half-life (t1/2) of NHC in plasma: Treatment A versus Treatment B
Time Frame: Pre-dose, and at designated timepoints up to 72 hours postdose
t1/2 of NHC in plasma will be determined.
Pre-dose, and at designated timepoints up to 72 hours postdose
Apparent Clearance (CL/F) of NHC in plasma: Treatment A versus Treatment B
Time Frame: Pre-dose, and at designated timepoints up to 72 hours postdose
CL/F of NHC in plasma will be determined.
Pre-dose, and at designated timepoints up to 72 hours postdose
Apparent volume of distribution during terminal phase (Vz/F) of NHC in plasma: Treatment A versus Treatment B
Time Frame: Pre-dose, and at designated timepoints up to 72 hours postdose
Vz/F of NHC in plasma will be determined.
Pre-dose, and at designated timepoints up to 72 hours postdose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC0-inf of NHC in plasma: Treatment B versus Treatment C
Time Frame: Pre-dose, and at designated timepoints up to 72 hours postdose
AUC0-inf of NHC in plasma will be determined.
Pre-dose, and at designated timepoints up to 72 hours postdose
AUC0-last of NHC in plasma: Treatment B versus Treatment C
Time Frame: Pre-dose, and at designated timepoints up to 72 hours postdose
AUC0-last of NHC in plasma will be determined.
Pre-dose, and at designated timepoints up to 72 hours postdose
AUC0-12 of NHC in plasma: Treatment B versus Treatment C
Time Frame: Pre-dose, and at designated timepoints up to 12 hours postdose
AUC0-12 of NHC in plasma will be determined.
Pre-dose, and at designated timepoints up to 12 hours postdose
Cmax of NHC in plasma: Treatment B versus Treatment C
Time Frame: Pre-dose, and at designated timepoints up to 72 hours postdose
Cmax of NHC in plasma will be determined.
Pre-dose, and at designated timepoints up to 72 hours postdose
Tmax of NHC in plasma: Treatment B versus Treatment C
Time Frame: Pre-dose, and at designated timepoints up to 72 hours postdose
Tmax of NHC in plasma will be determined.
Pre-dose, and at designated timepoints up to 72 hours postdose
t1/2 of NHC in plasma: Treatment B versus Treatment C
Time Frame: Pre-dose, and at designated timepoints up to 72 hours postdose
t1/2 of NHC in plasma will be determined.
Pre-dose, and at designated timepoints up to 72 hours postdose
CL/F of NHC in plasma: Treatment B versus Treatment C
Time Frame: Pre-dose, and at designated timepoints up to 72 hours postdose
CL/F of NHC in plasma will be determined.
Pre-dose, and at designated timepoints up to 72 hours postdose
Vz/F of NHC in plasma: Treatment B versus Treatment C
Time Frame: Pre-dose, and at designated timepoints up to 72 hours postdose
Vz/F of NHC in plasma will be determined.
Pre-dose, and at designated timepoints up to 72 hours postdose
AUC0-inf of NHC in plasma: Treatment D versus Treatment A
Time Frame: Pre-dose, and at designated timepoints up to 72 hours postdose
AUC0-inf of NHC in plasma will be determined.
Pre-dose, and at designated timepoints up to 72 hours postdose
AUC0-last of NHC in plasma: Treatment D versus Treatment A
Time Frame: Pre-dose, and at designated timepoints up to 72 hours postdose
AUC0-last of NHC in plasma will be determined.
Pre-dose, and at designated timepoints up to 72 hours postdose
AUC0-12 of NHC in plasma: Treatment D versus Treatment A
Time Frame: Pre-dose, and at designated timepoints up to 12 hours postdose
AUC0-12 of NHC in plasma will be determined.
Pre-dose, and at designated timepoints up to 12 hours postdose
Cmax of NHC in plasma: Treatment D versus Treatment A
Time Frame: Pre-dose, and at designated timepoints up to 72 hours postdose
Cmax of NHC in plasma will be determined.
Pre-dose, and at designated timepoints up to 72 hours postdose
Tmax of NHC in plasma: Treatment D versus Treatment A
Time Frame: Pre-dose, and at designated timepoints up to 72 hours postdose
Tmax of NHC in plasma will be determined.
Pre-dose, and at designated timepoints up to 72 hours postdose
t1/2 of NHC in plasma: Treatment D versus Treatment A
Time Frame: Pre-dose, and at designated timepoints up to 72 hours postdose
t1/2 of NHC in plasma will be determined.
Pre-dose, and at designated timepoints up to 72 hours postdose
CL/F of NHC in plasma: Treatment D versus Treatment A
Time Frame: Pre-dose, and at designated timepoints up to 72 hours postdose
CL/F of NHC in plasma will be determined.
Pre-dose, and at designated timepoints up to 72 hours postdose
Vz/F of NHC in plasma: Treatment D versus Treatment A
Time Frame: Pre-dose, and at designated timepoints up to 72 hours postdose
Vz/F of NHC in plasma will be determined.
Pre-dose, and at designated timepoints up to 72 hours postdose
Number of participants who experience one or more adverse events (AEs)
Time Frame: Up to ~ 38 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.
Up to ~ 38 days
Number of participants who discontinue study intervention due to an AE
Time Frame: Up to ~ 38 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.
Up to ~ 38 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2023

Primary Completion (Actual)

February 27, 2023

Study Completion (Actual)

March 15, 2023

Study Registration Dates

First Submitted

September 24, 2024

First Submitted That Met QC Criteria

September 24, 2024

First Posted (Actual)

September 27, 2024

Study Record Updates

Last Update Posted (Actual)

July 11, 2025

Last Update Submitted That Met QC Criteria

July 8, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4482-011
  • MK-4482-011 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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