HealthyPhase 1NCT06615869

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

A Phase 1 study testing Molnupiravir in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Molnupiravir
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 siteUnited States
Study dates: 20 Jan 2023to 15 Mar 2023
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

QPS-MRA, LLC-Early Phase (Site 0002)
South Miami, Florida, 33143

Other trials in United States

About this study

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

Conditions: Healthy
Being tested: Molnupiravir

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MolnupiravirDrug
Also called MK-4482, MOV, LAGEVRIO, EIDD-2801
Oral Administration.

Study groups in NCT06615869
Study group	Role	What they receive
Molnupiravir Treatment A	Experimental	Participants receive molnupiravir reference capsule. Receives: Drug: Molnupiravir
Molnupiravir Treatment B	Experimental	Participants receive molnupiravir Formulation 1. Receives: Drug: Molnupiravir
Molnupiravir Treatment C	Experimental	Participants receive molnupiravir Formulation 1 after a high-fat meal. Receives: Drug: Molnupiravir
Molnupiravir Treatment D	Experimental	Participants receive molnupiravir Formulation 2. Receives: Drug: Molnupiravir

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-dose, and at designated timepoints up to 72 hours postdose
Apparent Clearance (CL/F) of NHC in plasma: Treatment A versus Treatment B
CL/F of NHC in plasma will be determined.
Measured: 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.
Measured: Pre-dose, and at designated timepoints up to 72 hours postdose

Secondary outcomes (18)

AUC0-inf of NHC in plasma: Treatment B versus Treatment C
AUC0-inf of NHC in plasma will be determined.
Measured: Pre-dose, and at designated timepoints up to 72 hours postdose
AUC0-last of NHC in plasma: Treatment B versus Treatment C
AUC0-last of NHC in plasma will be determined.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to ~ 38 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jan 202315 Mar 2023

First posted27 Sep 2024
Study start20 Jan 2023
Primary completion27 Feb 2023
Study completion15 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06615869
Sponsor's protocol ID: 4482-011
Other IDs: MK-4482-011
Status last verified: Jul 2025
First submitted: 24 Sep 2024
Last updated: 11 Jul 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

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.
PubMed 39912659

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06615869
Acronym / sponsor ID: 4482-011
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 20 Jan 2023 (actual)
Primary completion: 27 Feb 2023 (actual)
Study completion: 15 Mar 2023 (actual)
First posted: 27 Sep 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Molnupiravir Treatment A	Experimental	Drug: MolnupiravirParticipants receive molnupiravir reference capsule.
Molnupiravir Treatment B	Experimental	Drug: MolnupiravirParticipants receive molnupiravir Formulation 1.
Molnupiravir Treatment C	Experimental	Drug: MolnupiravirParticipants receive molnupiravir Formulation 1 after a high-fat meal.
Molnupiravir Treatment D	Experimental	Drug: MolnupiravirParticipants receive molnupiravir Formulation 2.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Has body mass index (BMI) ≥18 kg/m^2 and ≤32 kg/m^2.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MolnupiravirAlso: MK-4482, MOV, LAGEVRIO, EIDD-2801Oral Administration.	Drug	Molnupiravir Treatment A, Molnupiravir Treatment B, Molnupiravir Treatment C, Molnupiravir Treatment D

Primary outcome

Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of N-Hydroxycitidine (NHC) in plasma: Treatment A versus Treatment B
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Pre-dose, and at designated timepoints up to 72 hours postdose
Vz/F of NHC in plasma will be determined.

18 secondary outcomes

AUC0-inf of NHC in plasma: Treatment B versus Treatment C
Time frame: Pre-dose, and at designated timepoints up to 72 hours postdose
AUC0-last of NHC in plasma: Treatment B versus Treatment C
Time frame: Pre-dose, and at designated timepoints up to 72 hours postdose
AUC0-12 of NHC in plasma: Treatment B versus Treatment C
Time frame: Pre-dose, and at designated timepoints up to 12 hours postdose
Cmax of NHC in plasma: Treatment B versus Treatment C
Time frame: Pre-dose, and at designated timepoints up to 72 hours postdose
Tmax of NHC in plasma: Treatment B versus Treatment C
Time frame: Pre-dose, and at designated timepoints up to 72 hours postdose
t1/2 of NHC in plasma: Treatment B versus Treatment C
Time frame: Pre-dose, and at designated timepoints up to 72 hours postdose
CL/F of NHC in plasma: Treatment B versus Treatment C
Time frame: Pre-dose, and at designated timepoints up to 72 hours postdose
Vz/F of NHC in plasma: Treatment B versus Treatment C
Time frame: Pre-dose, and at designated timepoints up to 72 hours postdose
AUC0-inf of NHC in plasma: Treatment D versus Treatment A
Time frame: Pre-dose, and at designated timepoints up to 72 hours postdose
AUC0-last of NHC in plasma: Treatment D versus Treatment A
Time frame: Pre-dose, and at designated timepoints up to 72 hours postdose
AUC0-12 of NHC in plasma: Treatment D versus Treatment A
Time frame: Pre-dose, and at designated timepoints up to 12 hours postdose
Cmax of NHC in plasma: Treatment D versus Treatment A
Time frame: Pre-dose, and at designated timepoints up to 72 hours postdose
Tmax of NHC in plasma: Treatment D versus Treatment A
Time frame: Pre-dose, and at designated timepoints up to 72 hours postdose
t1/2 of NHC in plasma: Treatment D versus Treatment A
Time frame: Pre-dose, and at designated timepoints up to 72 hours postdose
CL/F of NHC in plasma: Treatment D versus Treatment A
Time frame: Pre-dose, and at designated timepoints up to 72 hours postdose
Vz/F of NHC in plasma: Treatment D versus Treatment A
Time frame: Pre-dose, and at designated timepoints up to 72 hours postdose
Number of participants who experience one or more adverse events (AEs)
Time frame: Up to ~ 38 days
Number of participants who discontinue study intervention due to an AE
Time frame: Up to ~ 38 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
Results publication: PubMed 39912659Fiore 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.
Merck Clinical Trials InformationLink provided by the sponsor.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Molnupiravir in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Pre-dose, and at designated timepoints up to 72 hours postdose). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06615869, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.