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Completed

NCT Number: NCT06615869

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

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.

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

QPS-MRA, LLC-Early Phase (Site 0002)

South Miami, Florida, 33143, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Molnupiravir

Drug

Oral Administration.

Other names: MK-4482, MOV, LAGEVRIO, EIDD-2801

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 27, 2024
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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