HealthyPhase 1NCT06816030
A Clinical Study of MK-4482 in Chinese Healthy Male Participants (MK-4482-009)
A Phase 1 study testing MK-4482 in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in China.
Trial summary
The goal of the study is to learn what happens to MK-4482 after single and multiple doses in healthy Chinese participants over time. Researchers also want to learn about the safety of MK-4482, including how well people tolerate it. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MK-4482
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 28 Jun 2023to 5 Aug 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The main inclusion criteria include but are not limited to the following:
- Has a Body Mass Index (BMI) of 19 to 24 weight (kg)/height (m)2, inclusive, and body weight of ≥ 50 kg at the screening visit.
Who cannot join
- The main exclusion criteria include but are not limited to the following:
- Has a history of clinically significant abnormalities or diseases.
- Has history of cancer.
- Has a history of significant multiple and/or severe allergies.
- Had any major surgery.
- Has participated in another investigational study within 3 months prior to the screening visit.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital (Site 0001)
Beijing, Beijing Municipality, 100191
About this study
Official title: An Open-label Study to Characterize the Pharmacokinetics, Safety and Tolerability of Single and Multiple Oral Doses of MK-4482 in Chinese Healthy Male Participants
The goal of the study is to learn what happens to MK-4482 after single and multiple doses in healthy Chinese participants over time. Researchers also want to learn about the safety of MK-4482, including how well people tolerate it.
- Conditions
- Healthy
- Being tested
- MK-4482
- Keywords
- Coronavirus Disease (COVID-19)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-4482Drug
Participants in period 1 received, MK-4482 800 mg single oral dose in the morning on Day 1. Participants in period 2 received, MK-4482 800mg oral dose administered every 12 hours (Q12H) on Day 1 through Day 6 for11 doses.
| Study group | Role | What they receive |
|---|---|---|
| MK-4482 | Experimental | Participants in period 1 received, MK-4482 800 mg single oral dose in the morning on Day 1. Participants in period 2 received, MK-4482 800mg oral dose administered every 12 hours (Q12H) on Day 1 through Day 6 for11 doses. Receives: Drug: MK-4482 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Maximum Observed Plasma Concentration (Cmax) After Single Oral Dose of MK-4482 in Period 1
Cmax of N-hydroxycytidine (NHC) after a single oral dose of MK-4482 in period 1.
Measured: At designated time points up to 72 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax ) After Single Oral Dose of MK-4482 in Period 1.
Tmax of NHC following single oral dose of MK-4482 in period 1.
Measured: At designated time points up to 72 hours post-dose
Elimination Half Life (T1/2) After Single Oral Dose of MK-4482 in Period 1
T1/2 is defined as the time required for the concentration or amount of NHC in the body to be reduced by one-half after a single oral dose of MK-4482 in period 1.
Measured: At designated time points up to 72 hours post-dose
Apparent Total Clearance (CL/F) After Single Oral Dose of MK-4482 in Period 1
CL/F of NHC from plasma after single oral dose of MK-4482 in period 1.
Measured: At designated time points up to 72 hours post-dose
Apparent Volume of Distribution (Vz/F) After Single Oral Dose of MK-4482 in Period 1
Vz/F of NHC during terminal phase after single oral dose of MK-4482 in period 1.
Measured: At designated time points up to 72 hours post-dose
Area Under the Plasma Concentration-time Curve From Time 0 to 12 Hours Post-dose (AUC0-12hr) After Single Oral Dose of MK-4482 in Period 1
This is a measure of the average amount of NHC in the plasma over a period of 12 hours after single oral dose of MK-4482 in period 1.
Measured: At designated time points up to 72 hours post-dose
Area Under the Plasma Concentration-time Curve From Time Zero to Last Measurable Concentration (AUC0-last) After Single Oral Dose of MK-4482 in Period 1
AUC0-last of NHC following a single oral dose of MK-4482 in period 1.
Measured: At designated time points up to 72 hours post-dose
Area Under The Plasma Concentration Versus Time Curve From Time Zero (pre-dose) to Extrapolated Infinite Time (AUC0-inf) After Single Oral Dose of MK-4482 in Period 1
AUC0-inf of NHC after single oral dose of MK-4482 in period 1.
Measured: At designated time points up to 72 hours post-dose
The Maximum Observed Plasma Concentration (Cmax) After Multiple Oral Doses of MK-4482 in Period 2
Cmax of NHC after multiple oral doses of MK-4482 in period 2.
Measured: At designated time points up to 72 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax ) After Multiple Oral Doses of MK-4482 in Period 2
Tmax of NHC following multiple oral doses of MK-4482 in period 2.
Measured: At designated time points up to 72 hours post-dose
Elimination Half Life (T1/2) After Multiple Oral Doses of MK-4482 in Period 2
T1/2 is defined as the time required for the concentration or amount of NHC in the body to be reduced by one-half after multiple oral doses of MK-4482 in period 2.
Measured: At designated time points up to 72 hours post-dose
Clearance at Steady State (CLss/F) After Multiple Oral Doses of MK-4482 in Period 2
CLss/F of plasma NHC following multiple doses of MK-4482 in period 2.
Measured: At designated time points up to 72 hours post-dose
Apparent Volume of Distribution (Vz/F) After Multiple Oral Doses of MK-4482 in Period 2
Vz/F of NHC during terminal phase after multiple doses of MK-4482 in period 2.
Measured: At designated time points up to 72 hours post-dose
Area Under the Plasma Concentration-time Curve From Time 0 to 12 Hours Post-dose (AUC0-12hr) After Multiple Oral Doses of MK-4482 in Period 2
This is a measure of the average amount of NHC in the plasma over a period of 12 hours after multiple oral doses of MK-4482 in period 2.
Measured: At designated time points up to 72 hours post-dose
The Minimum Concentration (Ctrough) After Multiple Oral Doses of MK-4482 in Period 2
Ctrough of NHC that occurred following multiple doses of MK-4482 in period 2.
Measured: At designated time points up to 72 hours post-dose
Accumulation Ratio on Cmax After Multiple Oral Doses of MK-4482 in Period 2
The maximum concentration at steady state following multiple doses of MK-4482 in period 2 divided by the maximum concentration following the initial dosing in Period 1.
Measured: At designated time points up to 72 hours post-dose
Accumulation Ratio on AUC0-12hr After Multiple Oral Doses of MK-4482
The AUC0-12hr at steady state following multiple doses of MK-4482 in period 2 divided by the AUC0-12hr following the initial dosing in Period 1.
Measured: At designated time points up to 72 hours post-dose
Secondary outcomes (2)
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Measured: Up to ~ 5.5 weeks
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
Measured: Up to ~ 5.5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start28 Jun 2023
- Primary completion5 Aug 2023
- Study completion5 Aug 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
- Not applicable
- Intervention model
- Single group
- Model description
- Sequential model
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06816030
- Sponsor's protocol ID
- 4482-009
- Other IDs
- MK-4482-009
- Status last verified
- Apr 2026
- First submitted
- 4 Feb 2025
- Last updated
- 16 Apr 2026
- 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
Zhu J, Zhang D, Liu Z, Yan B, Zang Y, Zhao W, Sun F, Maas BM, Cheng MH, Stoch SA, Li H. Pharmacokinetics and Safety of Single and Multiple Doses of Molnupiravir in Healthy Male Chinese Adults: An Open-Label, Fixed Sequence, Phase 1 Study. Clin Transl Sci. 2026 Apr;19(4):e70481. doi: 10.1111/cts.70481.
PubMed 41904711
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study to Characterize the Pharmacokinetics, Safety and Tolerability of Single and Multiple Oral Doses of MK-4482 in Chinese Healthy Male Participants
- ClinicalTrials.gov ID
- NCT06816030
- Acronym / sponsor ID
- 4482-009
- Conditions
- Healthy
- Keywords
- Coronavirus Disease (COVID-19)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2023 (actual)
- Primary completion
- 5 Aug 2023 (actual)
- Study completion
- 5 Aug 2023 (actual)
- First posted
- 10 Feb 2025 (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.
The goal of the study is to learn what happens to MK-4482 after single and multiple doses in healthy Chinese participants over time. Researchers also want to learn about the safety of MK-4482, including how well people tolerate it.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Sequential model
| Arm | Type | Receives |
|---|---|---|
| MK-4482 | Experimental | Drug: MK-4482Participants in period 1 received, MK-4482 800 mg single oral dose in the morning on Day 1. Participants in period 2 received, MK-4482 800mg oral dose administered every 12 hours (Q12H) on Day 1 through Day 6 for11 doses. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Has a Body Mass Index (BMI) of 19 to 24 weight (kg)/height (m)2, inclusive, and body weight of ≥ 50 kg at the screening visit.
Key exclusion criteria (6 listed)
- Has a history of clinically significant abnormalities or diseases.
- Has history of cancer.
- Has a history of significant multiple and/or severe allergies.
- Had any major surgery.
- Has participated in another investigational study within 3 months prior to the screening visit.
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 |
|---|---|---|
| MK-4482Participants in period 1 received, MK-4482 800 mg single oral dose in the morning on Day 1. Participants in period 2 received, MK-4482 800mg oral dose administered every 12 hours (Q12H) on Day 1 through Day 6 for11 doses. | Drug | MK-4482 |
Primary outcome
The Maximum Observed Plasma Concentration (Cmax) After Single Oral Dose of MK-4482 in Period 1
Time frame: At designated time points up to 72 hours post-dose
Cmax of N-hydroxycytidine (NHC) after a single oral dose of MK-4482 in period 1.
Time to Reach Maximum Observed Plasma Concentration (Tmax ) After Single Oral Dose of MK-4482 in Period 1.
Time frame: At designated time points up to 72 hours post-dose
Tmax of NHC following single oral dose of MK-4482 in period 1.
Elimination Half Life (T1/2) After Single Oral Dose of MK-4482 in Period 1
Time frame: At designated time points up to 72 hours post-dose
T1/2 is defined as the time required for the concentration or amount of NHC in the body to be reduced by one-half after a single oral dose of MK-4482 in period 1.
Apparent Total Clearance (CL/F) After Single Oral Dose of MK-4482 in Period 1
Time frame: At designated time points up to 72 hours post-dose
CL/F of NHC from plasma after single oral dose of MK-4482 in period 1.
Apparent Volume of Distribution (Vz/F) After Single Oral Dose of MK-4482 in Period 1
Time frame: At designated time points up to 72 hours post-dose
Vz/F of NHC during terminal phase after single oral dose of MK-4482 in period 1.
Area Under the Plasma Concentration-time Curve From Time 0 to 12 Hours Post-dose (AUC0-12hr) After Single Oral Dose of MK-4482 in Period 1
Time frame: At designated time points up to 72 hours post-dose
This is a measure of the average amount of NHC in the plasma over a period of 12 hours after single oral dose of MK-4482 in period 1.
Area Under the Plasma Concentration-time Curve From Time Zero to Last Measurable Concentration (AUC0-last) After Single Oral Dose of MK-4482 in Period 1
Time frame: At designated time points up to 72 hours post-dose
AUC0-last of NHC following a single oral dose of MK-4482 in period 1.
Area Under The Plasma Concentration Versus Time Curve From Time Zero (pre-dose) to Extrapolated Infinite Time (AUC0-inf) After Single Oral Dose of MK-4482 in Period 1
Time frame: At designated time points up to 72 hours post-dose
AUC0-inf of NHC after single oral dose of MK-4482 in period 1.
The Maximum Observed Plasma Concentration (Cmax) After Multiple Oral Doses of MK-4482 in Period 2
Time frame: At designated time points up to 72 hours post-dose
Cmax of NHC after multiple oral doses of MK-4482 in period 2.
Time to Reach Maximum Observed Plasma Concentration (Tmax ) After Multiple Oral Doses of MK-4482 in Period 2
Time frame: At designated time points up to 72 hours post-dose
Tmax of NHC following multiple oral doses of MK-4482 in period 2.
Elimination Half Life (T1/2) After Multiple Oral Doses of MK-4482 in Period 2
Time frame: At designated time points up to 72 hours post-dose
T1/2 is defined as the time required for the concentration or amount of NHC in the body to be reduced by one-half after multiple oral doses of MK-4482 in period 2.
Clearance at Steady State (CLss/F) After Multiple Oral Doses of MK-4482 in Period 2
Time frame: At designated time points up to 72 hours post-dose
CLss/F of plasma NHC following multiple doses of MK-4482 in period 2.
Apparent Volume of Distribution (Vz/F) After Multiple Oral Doses of MK-4482 in Period 2
Time frame: At designated time points up to 72 hours post-dose
Vz/F of NHC during terminal phase after multiple doses of MK-4482 in period 2.
Area Under the Plasma Concentration-time Curve From Time 0 to 12 Hours Post-dose (AUC0-12hr) After Multiple Oral Doses of MK-4482 in Period 2
Time frame: At designated time points up to 72 hours post-dose
This is a measure of the average amount of NHC in the plasma over a period of 12 hours after multiple oral doses of MK-4482 in period 2.
The Minimum Concentration (Ctrough) After Multiple Oral Doses of MK-4482 in Period 2
Time frame: At designated time points up to 72 hours post-dose
Ctrough of NHC that occurred following multiple doses of MK-4482 in period 2.
Accumulation Ratio on Cmax After Multiple Oral Doses of MK-4482 in Period 2
Time frame: At designated time points up to 72 hours post-dose
The maximum concentration at steady state following multiple doses of MK-4482 in period 2 divided by the maximum concentration following the initial dosing in Period 1.
Accumulation Ratio on AUC0-12hr After Multiple Oral Doses of MK-4482
Time frame: At designated time points up to 72 hours post-dose
The AUC0-12hr at steady state following multiple doses of MK-4482 in period 2 divided by the AUC0-12hr following the initial dosing in Period 1.
2 secondary outcomes
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to ~ 5.5 weeks
Number of Participants Who Discontinue Study Treatment Due to an AE
Time frame: Up to ~ 5.5 weeks
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 16 Apr 2026.
- Results publication: PubMed 41904711Zhu J, Zhang D, Liu Z, Yan B, Zang Y, Zhao W, Sun F, Maas BM, Cheng MH, Stoch SA, Li H. Pharmacokinetics and Safety of Single and Multiple Doses of Molnupiravir in Healthy Male Chinese Adults: An Open-Label, Fixed Sequence, Phase 1 Study. Clin Transl Sci. 2026 Apr;19(4):e70481. doi: 10.1111/cts.70481.
- 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 MK-4482 in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in China.
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 6 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 16 Apr 2026. 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 China. 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?
The Maximum Observed Plasma Concentration (Cmax) After Single Oral Dose of MK-4482 in Period 1 (time frame: At designated time points up to 72 hours post-dose). The study lists 17 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 NCT06816030, 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 16 Apr 2026.