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

NCT06615869 | Completed Phase 1 FDA Drug

• 2 other identifiers: 4482-011MK-4482-011
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (8)

• Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of N-Hydroxycitidine (NHC) in plasma: Treatment A versus Treatment B

  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

  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

  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

  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

  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

  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

  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

  Vz/F of NHC in plasma will be determined.

  Pre-dose, and at designated timepoints up to 72 hours postdose

Secondary Outcomes (18)

• AUC0-inf of NHC in plasma: Treatment B versus Treatment C

  Pre-dose, and at designated timepoints up to 72 hours postdose

• AUC0-last of NHC in plasma: Treatment B versus Treatment C

  Pre-dose, and at designated timepoints up to 72 hours postdose

• AUC0-12 of NHC in plasma: Treatment B versus Treatment C

  Pre-dose, and at designated timepoints up to 12 hours postdose

• Cmax of NHC in plasma: Treatment B versus Treatment C

  Pre-dose, and at designated timepoints up to 72 hours postdose

• Tmax of NHC in plasma: Treatment B versus Treatment C

  Pre-dose, and at designated timepoints up to 72 hours postdose

Study Arms (4)

Molnupiravir Treatment A

EXPERIMENTAL

Participants receive molnupiravir reference capsule.

Drug: Molnupiravir

Molnupiravir Treatment B

EXPERIMENTAL

Participants receive molnupiravir Formulation 1.

Drug: Molnupiravir

Molnupiravir Treatment C

EXPERIMENTAL

Participants receive molnupiravir Formulation 1 after a high-fat meal.

Drug: Molnupiravir

Molnupiravir Treatment D

EXPERIMENTAL

Participants receive molnupiravir Formulation 2.

Drug: Molnupiravir

Interventions

Molnupiravir DRUG

Oral Administration.

Also known as: MK-4482, MOV, LAGEVRIO, EIDD-2801

Molnupiravir Treatment A; Molnupiravir Treatment B; Molnupiravir Treatment C; Molnupiravir Treatment D

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

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

South Miami, Florida, 33143, United States

Location

Related Publications (1)

• Fiore JL, Jin Y, Heimbach T, Patel SR, Zhao T, Matthews CZ, Pagnussat S, Maas BM, Cheng MH, Stoch SA. Pharmacokinetics and bioequivalence of a molnupiravir tablet formulation compared with the molnupiravir capsule formulation in healthy adult participants-a randomized, open-label, three-period, crossover study. Antimicrob Agents Chemother. 2025 Mar 5;69(3):e0143424. doi: 10.1128/aac.01434-24. Epub 2025 Feb 6.

  PMID: 39912659 RESULT

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

molnupiravir

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: September 27, 2024
• Study Start: January 20, 2023
• Primary Completion: February 27, 2023
• Study Completion: March 15, 2023
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)