Study

Overview

Official Title: 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 Type:

Interventional

Study Phase:

Phase 1

Enrollment:

64

Study Start Date:

January 2023

Study Completion Date:

March 2023

Primary Completion Date:

February 2023

Eligibility

Ages Eligible for Study:

18 years to 60 years

Genders Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

CRITERIA

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.

Locations

No Contacts or Locations in US/Canada Provided

Results

No Study Results Posted

Study Detail

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

Overview

Eligibility

CRITERIA

Locations

Results