A Study to Evaluate Molnupiravir Tablet Formulation Compared to the Molnupiravir Capsule Formulation in Healthy Adult Participants (MK-4482-011)
- Conditions
- Healthy
- Interventions
- Drug: Molnupiravir
- Registration Number
- NCT06615869
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Molnupiravir Treatment A Molnupiravir Participants receive molnupiravir reference capsule. Molnupiravir Treatment C Molnupiravir Participants receive molnupiravir Formulation 1 after a high-fat meal. Molnupiravir Treatment D Molnupiravir Participants receive molnupiravir Formulation 2. Molnupiravir Treatment B Molnupiravir Participants receive molnupiravir Formulation 1.
- Primary Outcome Measures
Name Time Method Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of N-Hydroxycitidine (NHC) in plasma: Treatment A versus Treatment B Pre-dose, and at designated timepoints up to 72 hours postdose AUC0-inf of NHC in plasma will be determined.
Area Under the Concentration-Time Curve From Time Zero to last measurable timepoint (AUC0-last) of NHC in plasma: Treatment A versus Treatment B Pre-dose, and at designated timepoints up to 72 hours postdose AUC0-last of NHC in plasma will be determined.
Area Under the Concentration-Time Curve From Time Zero to 12 hours (AUC0-12) of (NHC) in plasma: Treatment A versus Treatment B Pre-dose, and at designated timepoints up to 12 hours postdose AUC0-12 of NHC in plasma will be determined.
Maximum plasma concentration (Cmax) of NHC: Treatment A versus Treatment B Pre-dose, and at designated timepoints up to 72 hours postdose Cmax of NHC in plasma will be determined.
Time to maximum plasma concentration (Tmax) of NHC: Treatment A versus Treatment B Pre-dose, and at designated timepoints up to 72 hours postdose Tmax of NHC in plasma will be determined.
Apparent terminal half-life (t1/2) of NHC in plasma: Treatment A versus Treatment B Pre-dose, and at designated timepoints up to 72 hours postdose t1/2 of NHC in plasma will be determined.
Apparent Clearance (CL/F) of NHC in plasma: Treatment A versus Treatment B Pre-dose, and at designated timepoints up to 72 hours postdose CL/F of NHC in plasma will be determined.
Apparent volume of distribution during terminal phase (Vz/F) of NHC in plasma: Treatment A versus Treatment B Pre-dose, and at designated timepoints up to 72 hours postdose Vz/F of NHC in plasma will be determined.
- Secondary Outcome Measures
Name Time Method AUC0-inf of NHC in plasma: Treatment B versus Treatment C Pre-dose, and at designated timepoints up to 72 hours postdose AUC0-inf of NHC in plasma will be determined.
AUC0-last 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 will be determined.
AUC0-12 of NHC in plasma: Treatment B versus Treatment C Pre-dose, and at designated timepoints up to 12 hours postdose AUC0-12 of NHC in plasma will be determined.
Cmax of NHC in plasma: Treatment B versus Treatment C Pre-dose, and at designated timepoints up to 72 hours postdose Cmax of NHC in plasma will be determined.
Tmax 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 will be determined.
t1/2 of NHC in plasma: Treatment B versus Treatment C Pre-dose, and at designated timepoints up to 72 hours postdose t1/2 of NHC in plasma will be determined.
CL/F of NHC in plasma: Treatment B versus Treatment C Pre-dose, and at designated timepoints up to 72 hours postdose CL/F of NHC in plasma will be determined.
Vz/F of NHC in plasma: Treatment B versus Treatment C Pre-dose, and at designated timepoints up to 72 hours postdose Vz/F of NHC in plasma will be determined.
AUC0-inf of NHC in plasma: Treatment D versus Treatment A Pre-dose, and at designated timepoints up to 72 hours postdose AUC0-inf of NHC in plasma will be determined.
AUC0-last of NHC in plasma: Treatment D versus Treatment A Pre-dose, and at designated timepoints up to 72 hours postdose AUC0-last of NHC in plasma will be determined.
AUC0-12 of NHC in plasma: Treatment D versus Treatment A Pre-dose, and at designated timepoints up to 12 hours postdose AUC0-12 of NHC in plasma will be determined.
Cmax of NHC in plasma: Treatment D versus Treatment A Pre-dose, and at designated timepoints up to 72 hours postdose Cmax of NHC in plasma will be determined.
Tmax of NHC in plasma: Treatment D versus Treatment A Pre-dose, and at designated timepoints up to 72 hours postdose Tmax of NHC in plasma will be determined.
t1/2 of NHC in plasma: Treatment D versus Treatment A Pre-dose, and at designated timepoints up to 72 hours postdose t1/2 of NHC in plasma will be determined.
CL/F of NHC in plasma: Treatment D versus Treatment A Pre-dose, and at designated timepoints up to 72 hours postdose CL/F of NHC in plasma will be determined.
Vz/F of NHC in plasma: Treatment D versus Treatment A Pre-dose, and at designated timepoints up to 72 hours postdose Vz/F of NHC in plasma will be determined.
Number of participants who experience one or more adverse events (AEs) Up to ~ 38 days An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Number of participants who discontinue study intervention due to an AE Up to ~ 38 days An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Trial Locations
- Locations (1)
QPS-MRA, LLC-Early Phase (Site 0002)
🇺🇸South Miami, Florida, United States