Healthy
Conditions
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.
Interventions
DRUGMolnupiravir
Oral Administration.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed