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| ID | Type | Description | Link |
|---|---|---|---|
| MK-4482-011 | Other Identifier | MSD |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Molnupiravir Treatment A | Experimental | Participants receive molnupiravir reference capsule. |
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| Molnupiravir Treatment B | Experimental | Participants receive molnupiravir Formulation 1. |
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| Molnupiravir Treatment C | Experimental | Participants receive molnupiravir Formulation 1 after a high-fat meal. |
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| Molnupiravir Treatment D | Experimental | Participants receive molnupiravir Formulation 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Molnupiravir | Drug | Oral Administration. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of N-Hydroxycitidine (NHC) in plasma: Treatment A versus Treatment B | AUC0-inf of NHC in plasma will be determined. | Pre-dose, and at designated timepoints up to 72 hours postdose |
| Area Under the Concentration-Time Curve From Time Zero to last measurable timepoint (AUC0-last) of NHC in plasma: Treatment A versus Treatment B | AUC0-last of NHC in plasma will be determined. | Pre-dose, and at designated timepoints up to 72 hours postdose |
| Area Under the Concentration-Time Curve From Time Zero to 12 hours (AUC0-12) of (NHC) in plasma: Treatment A versus Treatment B | AUC0-12 of NHC in plasma will be determined. | Pre-dose, and at designated timepoints up to 12 hours postdose |
| Maximum plasma concentration (Cmax) of NHC: Treatment A versus Treatment B | Cmax of NHC in plasma will be determined. | Pre-dose, and at designated timepoints up to 72 hours postdose |
| Time to maximum plasma concentration (Tmax) of NHC: Treatment A versus Treatment B | Tmax of NHC in plasma will be determined. | Pre-dose, and at designated timepoints up to 72 hours postdose |
| Apparent terminal half-life (t1/2) of NHC in plasma: Treatment A versus Treatment B | t1/2 of NHC in plasma will be determined. | Pre-dose, and at designated timepoints up to 72 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-inf of NHC in plasma: Treatment B versus Treatment C | AUC0-inf of NHC in plasma will be determined. | Pre-dose, and at designated timepoints up to 72 hours postdose |
| AUC0-last of NHC in plasma: Treatment B versus Treatment C |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| QPS-MRA, LLC-Early Phase (Site 0002) | South Miami | Florida | 33143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39912659 | Result | Fiore JL, Jin Y, Heimbach T, Patel SR, Zhao T, Matthews CZ, Pagnussat S, Maas BM, Cheng MH, Stoch SA. Pharmacokinetics and bioequivalence of a molnupiravir tablet formulation compared with the molnupiravir capsule formulation in healthy adult participants-a randomized, open-label, three-period, crossover study. Antimicrob Agents Chemother. 2025 Mar 5;69(3):e0143424. doi: 10.1128/aac.01434-24. Epub 2025 Feb 6. |
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Term |
|---|---|
| C000656703 | molnupiravir |
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| Apparent Clearance (CL/F) of NHC in plasma: Treatment A versus Treatment B |
CL/F of NHC in plasma will be determined. |
| Pre-dose, and at designated timepoints up to 72 hours postdose |
| Apparent volume of distribution during terminal phase (Vz/F) of NHC in plasma: Treatment A versus Treatment B | Vz/F of NHC in plasma will be determined. | Pre-dose, and at designated timepoints up to 72 hours postdose |
AUC0-last of NHC in plasma will be determined.
| Pre-dose, and at designated timepoints up to 72 hours postdose |
| AUC0-12 of NHC in plasma: Treatment B versus Treatment C | AUC0-12 of NHC in plasma will be determined. | Pre-dose, and at designated timepoints up to 12 hours postdose |
| Cmax of NHC in plasma: Treatment B versus Treatment C | Cmax of NHC in plasma will be determined. | Pre-dose, and at designated timepoints up to 72 hours postdose |
| Tmax of NHC in plasma: Treatment B versus Treatment C | Tmax of NHC in plasma will be determined. | Pre-dose, and at designated timepoints up to 72 hours postdose |
| t1/2 of NHC in plasma: Treatment B versus Treatment C | t1/2 of NHC in plasma will be determined. | Pre-dose, and at designated timepoints up to 72 hours postdose |
| CL/F of NHC in plasma: Treatment B versus Treatment C | CL/F of NHC in plasma will be determined. | Pre-dose, and at designated timepoints up to 72 hours postdose |
| Vz/F of NHC in plasma: Treatment B versus Treatment C | Vz/F of NHC in plasma will be determined. | Pre-dose, and at designated timepoints up to 72 hours postdose |
| AUC0-inf of NHC in plasma: Treatment D versus Treatment A | AUC0-inf of NHC in plasma will be determined. | Pre-dose, and at designated timepoints up to 72 hours postdose |
| AUC0-last of NHC in plasma: Treatment D versus Treatment A | AUC0-last of NHC in plasma will be determined. | Pre-dose, and at designated timepoints up to 72 hours postdose |
| AUC0-12 of NHC in plasma: Treatment D versus Treatment A | AUC0-12 of NHC in plasma will be determined. | Pre-dose, and at designated timepoints up to 12 hours postdose |
| Cmax of NHC in plasma: Treatment D versus Treatment A | Cmax of NHC in plasma will be determined. | Pre-dose, and at designated timepoints up to 72 hours postdose |
| Tmax of NHC in plasma: Treatment D versus Treatment A | Tmax of NHC in plasma will be determined. | Pre-dose, and at designated timepoints up to 72 hours postdose |
| t1/2 of NHC in plasma: Treatment D versus Treatment A | t1/2 of NHC in plasma will be determined. | Pre-dose, and at designated timepoints up to 72 hours postdose |
| CL/F of NHC in plasma: Treatment D versus Treatment A | CL/F of NHC in plasma will be determined. | Pre-dose, and at designated timepoints up to 72 hours postdose |
| Vz/F of NHC in plasma: Treatment D versus Treatment A | Vz/F of NHC in plasma will be determined. | Pre-dose, and at designated timepoints up to 72 hours postdose |
| Number of participants who experience one or more adverse events (AEs) | 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. | Up to ~ 38 days |
| Number of participants who discontinue study intervention due to an AE | 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. | Up to ~ 38 days |