HealthyPhase 1NCT07919028
A Clinical Trial of MK-7602 in Healthy Volunteers (MK-7602-006)
A Phase 1 study testing MK-7602 and Pyronaridine in people with Healthy, run by Merck Sharp & Dohme LLC.
Trial summary
MK-7602 is a new medicine that is being studied to treat malaria. Malaria is a disease caused by a parasite that spreads to people through mosquito bites. Symptoms of malaria include fever, chills, and flu-like illness. If malaria is not treated, some people can have serious problems that can be deadly. 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?
- MK-7602 and Pyronaridine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 4 Jan 2027to 5 Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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:
- Is in good health
- Has a body mass index (BMI) between 18 and 32 kg/m^2, inclusive
Who cannot join
- The main exclusion criteria include but are not limited to the following:
- Has history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- Has a history of cancer (malignancy)
About this study
Official title: A Clinical Study to Evaluate the Effect of Pyronaridine on the Pharmacokinetics of MK-7602 in Healthy Participants
MK-7602 is a new medicine that is being studied to treat malaria. Malaria is a disease caused by a parasite that spreads to people through mosquito bites. Symptoms of malaria include fever, chills, and flu-like illness. If malaria is not treated, some people can have serious problems that can be deadly.
The goal of this trial is to learn what happens to MK-7602 in a person's body over time (a pharmacokinetic or PK trial). Researchers will compare what happens to MK-7602 in people's blood when it is taken alone (Period 1) and in combination with another medicine called pyronaridine (Period 2). Researchers also want to learn about the safety of MK-7602 taken with and without pyronaridine and if people tolerate them.
- Conditions
- Healthy
- Being tested
- MK-7602, Pyronaridine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-7602Drug
Oral administration
PyronaridineDrug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Period 1: MK-7602 | Experimental | Participants will receive an oral dose of MK-7602 once daily on Days 1, 2, and 3 of Period 1. Receives: Drug: MK-7602 |
| Period 2: MK-7602 + Pyronaridine | Experimental | Participants will receive oral doses of MK-7602 and pyronaridine once daily on Days 1, 2, and 3 of Period 2. Receives: Drug: MK-7602; Drug: Pyronaridine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve From Time 0 to the Next Dosing Interval (AUC0-tau) of MK-7602
Blood samples will be collected to determine the AUC0-tau of MK-7602 with and without pyronaridine.
Measured: At designated timepoints (up to approximately 21 days)
Maximum Plasma Concentration (Cmax) of MK-7602
Blood samples will be collected to determine the Cmax of MK-7602 with and without pyronaridine.
Measured: At designated timepoints (up to approximately 21 days)
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of trial intervention, whether or not considered related to the trial intervention. The number of participants who experience an AE will be reported.
Measured: Up to approximately 2 months
Number of Participants Who Discontinue Study Intervention Due to an AE
An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of trial intervention, whether or not considered related to the trial intervention. The number of participants who discontinue study intervention due to an AE will be reported.
Measured: Up to approximately 20 days
Secondary outcomes (2)
AUC0-tau of MK-7602
Blood samples will be collected to determine the AUC0-tau of MK-7602 with and without pyronaridine.
Measured: At designated timepoints (up to approximately 19 days)
Cmax of MK-7602
Blood samples will be collected to determine the Cmax of MK-7602 with and without pyronaridine.
Measured: At designated timepoints (up to approximately 19 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start4 Jan 2027 (estimated)
- Primary completion5 Apr 2027 (estimated)
- Study completion5 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
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
- NCT07919028
- Sponsor's protocol ID
- 7602-006
- Other IDs
- MK-7602-006
- Status last verified
- Sep 2026
- First submitted
- 30 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Effect of Pyronaridine on the Pharmacokinetics of MK-7602 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07919028
- Acronym / sponsor ID
- 7602-006
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 4 Jan 2027 (estimated)
- Primary completion
- 5 Apr 2027 (estimated)
- Study completion
- 5 Apr 2027 (estimated)
- First posted
- 5 Nov 2026 (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.
MK-7602 is a new medicine that is being studied to treat malaria. Malaria is a disease caused by a parasite that spreads to people through mosquito bites. Symptoms of malaria include fever, chills, and flu-like illness. If malaria is not treated, some people can have serious problems that can be deadly.
The goal of this trial is to learn what happens to MK-7602 in a person's body over time (a pharmacokinetic or PK trial). Researchers will compare what happens to MK-7602 in people's blood when it is taken alone (Period 1) and in combination with another medicine called pyronaridine (Period 2). Researchers also want to learn about the safety of MK-7602 taken with and without pyronaridine and if people tolerate them.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Period 1: MK-7602 | Experimental | Drug: MK-7602Participants will receive an oral dose of MK-7602 once daily on Days 1, 2, and 3 of Period 1. |
| Period 2: MK-7602 + Pyronaridine | Experimental | Drug: MK-7602, Drug: PyronaridineParticipants will receive oral doses of MK-7602 and pyronaridine once daily on Days 1, 2, and 3 of Period 2. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Is in good health
- Has a body mass index (BMI) between 18 and 32 kg/m^2, inclusive
Key exclusion criteria (3 listed)
- Has history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- Has a history of cancer (malignancy)
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-7602Oral administration | Drug | Period 1: MK-7602, Period 2: MK-7602 + Pyronaridine |
| PyronaridineOral administration | Drug | Period 2: MK-7602 + Pyronaridine |
Primary outcome
Area Under the Curve From Time 0 to the Next Dosing Interval (AUC0-tau) of MK-7602
Time frame: At designated timepoints (up to approximately 21 days)
Blood samples will be collected to determine the AUC0-tau of MK-7602 with and without pyronaridine.
Maximum Plasma Concentration (Cmax) of MK-7602
Time frame: At designated timepoints (up to approximately 21 days)
Blood samples will be collected to determine the Cmax of MK-7602 with and without pyronaridine.
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 2 months
An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of trial intervention, whether or not considered related to the trial intervention. The number of participants who experience an AE will be reported.
Number of Participants Who Discontinue Study Intervention Due to an AE
Time frame: Up to approximately 20 days
An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of trial intervention, whether or not considered related to the trial intervention. The number of participants who discontinue study intervention due to an AE will be reported.
2 secondary outcomes
AUC0-tau of MK-7602
Time frame: At designated timepoints (up to approximately 19 days)
Cmax of MK-7602
Time frame: At designated timepoints (up to approximately 19 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/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.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MK-7602 and Pyronaridine in people with Healthy, run by Merck Sharp & Dohme LLC.
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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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 Curve From Time 0 to the Next Dosing Interval (AUC0-tau) of MK-7602 (time frame: At designated timepoints (up to approximately 21 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2026.