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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-20

Study Completion Date

2023-03-15

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Molnupiravir Treatment A

Participants receive molnupiravir reference capsule.

Group Type EXPERIMENTAL

Molnupiravir

Intervention Type DRUG

Oral Administration.

Molnupiravir Treatment B

Participants receive molnupiravir Formulation 1.

Group Type EXPERIMENTAL

Molnupiravir

Intervention Type DRUG

Oral Administration.

Molnupiravir Treatment C

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

Group Type EXPERIMENTAL

Molnupiravir

Intervention Type DRUG

Oral Administration.

Molnupiravir Treatment D

Participants receive molnupiravir Formulation 2.

Group Type EXPERIMENTAL

Molnupiravir

Intervention Type DRUG

Oral Administration.

Interventions

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Molnupiravir

Oral Administration.

Intervention Type DRUG

Other Intervention Names

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MK-4482 MOV LAGEVRIO EIDD-2801

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes