Clinical trial NCT06615869: A Study to Evaluate Molnupiravir Tablet Formulation Compared to the Molnupiravir Capsule Formulation in Healthy Adult Participants (MK-4482-011)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-09-27
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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.

Primary outcomes:
measure: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of N-Hydroxycitidine (NHC) in plasma: Treatment A versus Treatment B
timeFrame: Pre-dose, and at designated timepoints up to 72 hours postdose
measure: Area Under the Concentration-Time Curve From Time Zero to last measurable timepoint (AUC0-last) of NHC in plasma: Treatment A versus Treatment B
timeFrame: Pre-dose, and at designated timepoints up to 72 hours postdose
measure: Area Under the Concentration-Time Curve From Time Zero to 12 hours (AUC0-12) of (NHC) in plasma: Treatment A versus Treatment B
timeFrame: Pre-dose, and at designated timepoints up to 12 hours postdose
measure: Maximum plasma concentration (Cmax) of NHC: Treatment A versus Treatment B
timeFrame: Pre-dose, and at designated timepoints up to 72 hours postdose
measure: Time to maximum plasma concentration (Tmax) of NHC: Treatment A versus Treatment B
timeFrame: Pre-dose, and at designated timepoints up to 72 hours postdose
measure: Apparent terminal half-life (t1/2) of NHC in plasma: Treatment A versus Treatment B
timeFrame: Pre-dose, and at designated timepoints up to 72 hours postdose
measure: Apparent Clearance (CL/F) of NHC in plasma: Treatment A versus Treatment B
timeFrame: Pre-dose, and at designated timepoints up to 72 hours postdose
measure: Apparent volume of distribution during terminal phase (Vz/F) of NHC in plasma: Treatment A versus Treatment B
timeFrame: Pre-dose, and at designated timepoints up to 72 hours postdose
Secondary outcomes:
measure: AUC0-inf of NHC in plasma: Treatment B versus Treatment C
timeFrame: Pre-dose, and at designated timepoints up to 72 hours postdose
measure: AUC0-last of NHC in plasma: Treatment B versus Treatment C
timeFrame: Pre-dose, and at designated timepoints up to 72 hours postdose
measure: AUC0-12 of NHC in plasma: Treatment B versus Treatment C
timeFrame: Pre-dose, and at designated timepoints up to 12 hours postdose
measure: Cmax of NHC in plasma: Treatment B versus Treatment C
timeFrame: Pre-dose, and at designated timepoints up to 72 hours postdose
measure: Tmax of NHC in plasma: Treatment B versus Treatment C
timeFrame: Pre-dose, and at designated timepoints up to 72 hours postdose
measure: t1/2 of NHC in plasma: Treatment B versus Treatment C
timeFrame: Pre-dose, and at designated timepoints up to 72 hours postdose
measure: CL/F of NHC in plasma: Treatment B versus Treatment C
timeFrame: Pre-dose, and at designated timepoints up to 72 hours postdose
measure: Vz/F of NHC in plasma: Treatment B versus Treatment C
timeFrame: Pre-dose, and at designated timepoints up to 72 hours postdose
measure: AUC0-inf of NHC in plasma: Treatment D versus Treatment A
timeFrame: Pre-dose, and at designated timepoints up to 72 hours postdose
measure: AUC0-last of NHC in plasma: Treatment D versus Treatment A
timeFrame: Pre-dose, and at designated timepoints up to 72 hours postdose
measure: AUC0-12 of NHC in plasma: Treatment D versus Treatment A
timeFrame: Pre-dose, and at designated timepoints up to 12 hours postdose
measure: Cmax of NHC in plasma: Treatment D versus Treatment A
timeFrame: Pre-dose, and at designated timepoints up to 72 hours postdose
measure: Tmax of NHC in plasma: Treatment D versus Treatment A
timeFrame: Pre-dose, and at designated timepoints up to 72 hours postdose
measure: t1/2 of NHC in plasma: Treatment D versus Treatment A
timeFrame: Pre-dose, and at designated timepoints up to 72 hours postdose
measure: CL/F of NHC in plasma: Treatment D versus Treatment A
timeFrame: Pre-dose, and at designated timepoints up to 72 hours postdose
measure: Vz/F of NHC in plasma: Treatment D versus Treatment A
timeFrame: Pre-dose, and at designated timepoints up to 72 hours postdose
measure: Number of participants who experience one or more adverse events (AEs)
timeFrame: Up to ~ 38 days
measure: Number of participants who discontinue study intervention due to an AE
timeFrame: Up to ~ 38 days
Other outcomes:
Locations:
city: South Miami
country: United States
facility: QPS-MRA, LLC-Early Phase (Site 0002)
state: Florida
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: