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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Molnupiravir

Study type: Interventional

Funder types: Industry

Identifiers

NCT06615869

4482-011

MK-4482-011 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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64 participants in 4 patient groups

Molnupiravir Treatment A

Experimental group

Description:

Participants receive molnupiravir reference capsule.

Treatment:

Drug: Molnupiravir

Molnupiravir Treatment B

Experimental group

Description:

Participants receive molnupiravir Formulation 1.

Treatment:

Drug: Molnupiravir

Molnupiravir Treatment C

Experimental group

Description:

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

Treatment:

Drug: Molnupiravir

Molnupiravir Treatment D

Experimental group

Description:

Participants receive molnupiravir Formulation 2.

Treatment:

Drug: Molnupiravir