HealthyPhase 1NCT07121959
A Study of Belzutifan (MK-6482) and Metformin in Healthy Adult Participants (MK-6482-039)
A Phase 1 study testing Metformin and Belzutifan in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial summary
The goal of this study is to learn how belzutifan (MK-6482) affects the levels of metformin in a healthy person's body over time. Researchers will study levels of metformin in the blood and urine in healthy volunteers after taking metformin alone (Period 1) and metformin with belzutifan (Period 2). 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?
- Metformin and Belzutifan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2025to 26 Sep 2025
- 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
The main inclusion criteria include, but are not limited to:
- Is a continuous non-smoker for at least 3 months prior to dosing
- Has body mass index (BMI) ≥ 18.0 and ≤ 42.0 kg/m2
- Is able to swallow multiple tablets
The main exclusion criteria include, but are not limited to:
- Has a history of cancer (malignancy)
- Has a history of anemia within the last 5 years
- Has a known history or presence of metabolic acidosis, ketoacidosis, or lactic acidosis
- Has a hemoglobin level below the lower limit of normal
- Has a pulse oximetry reading less than 92% at rest
- Is known to be a cytochrome P450 (CYP2C19) poor metabolizer or likely poor metabolizer based on genotyping prior to the screening visit or is determined to be a CYP2C19 poor metabolizer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Phase 1 Study to Characterize the Effects of Belzutifan on the Pharmacokinetics of a MATE1/2K Substrate, Metformin, in Healthy Adult Participants
The goal of this study is to learn how belzutifan (MK-6482) affects the levels of metformin in a healthy person's body over time. Researchers will study levels of metformin in the blood and urine in healthy volunteers after taking metformin alone (Period 1) and metformin with belzutifan (Period 2).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Metformin HCl
Oral Tablet
BelzutifanDrug
Also called MK-6482
Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Experimental | On Day 1 of Period 1, a single dose of metformin will be administered. Receives: Drug: Metformin |
| Belzutifan with Metformin | Experimental | In Period 2, belzutifan will be administered every day for 5 consecutive days with a single dose of metformin coadministered on Day 4. Receives: Drug: Metformin; Drug: Belzutifan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) for Metformin in Plasma
Blood samples will be collected to determine the AUC0-inf of metformin in plasma.
Measured: At designated timepoints (up to approximately 48 hours post-dose metformin)
Secondary outcomes (13)
Number of Participants Who Experience One or More Adverse Events (AEs)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Measured: Up to approximately 4 weeks
Number of Participants Who Discontinue Study Drug Due to an AE
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Measured: Up to approximately 2 weeks
Area Under the Concentration Versus Time Curve from 0 to the Last Quantifiable Sample (AUC0-last) of Metformin
Plasma samples will be collected to determine the AUC0-last of metformin.
Measured: At designated timepoints (up to approximately 48 hours post-dose metformin)
Area Under the Concentration Versus Time Curve from 0 to 24 hours (AUC0-24) of Metformin
Plasma samples will be collected to determine the AUC0-24 of metformin.
Measured: At designated timepoints (up to approximately 24 hours post-dose metformin)
Maximum Observed Concentration (Cmax) of Metformin
Plasma samples will be collected to determine the Cmax of metformin.
Measured: At designated timepoints (up to approximately 48 hours post-dose metformin)
Plasma Drug Concentration of Metformin at Hour 24 (C24)
Plasma samples will be collected to determine the C24 of metformin.
Measured: 24 hours post-dose metformin
Time to Maximum Concentration (Tmax) of Metformin
Plasma samples will be collected to determine the Tmax of metformin.
Measured: At designated timepoints (up to approximately 48 hours post-dose metformin)
Apparent Terminal Half-life (t1/2) of Metformin
Plasma samples will be collected to determine the t1/2 of metformin.
Measured: At designated timepoints (up to approximately 48 hours post-dose metformin)
Apparent Clearance (CL/F) of Metformin
Plasma samples will be collected to determine the CL/F of metformin.
Measured: At designated timepoints (up to approximately 48 hours post-dose metformin)
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Metformin
Plasma samples will be collected to determine the Vz/F of metformin.
Measured: At designated timepoints (up to approximately 48 hours post-dose metformin)
Total Amount of Metformin Excreted Unchanged in the Urine
Urine samples will be collected to determine the total amount of metformin excreted unchanged in the urine.
Measured: At designated timepoints (up to approximately 48 hours post-dose metformin)
Percentage of Metformin Excreted Unchanged in Urine
Urine samples will be collected to determine the percentage of metformin excreted unchanged in urine.
Measured: At designated timepoints (up to approximately 48 hours post-dose metformin)
Renal Clearance of Metformin
Urine samples will be collected to determine the renal clearance of metformin.
Measured: At designated timepoints (up to approximately 48 hours post-dose metformin)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start18 Aug 2025
- Primary completion13 Sep 2025
- Study completion26 Sep 2025
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 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
- NCT07121959
- Sponsor's protocol ID
- 6482-039
- Other IDs
- MK-6482-039
- Status last verified
- Oct 2025
- First submitted
- 12 Aug 2025
- Last updated
- 15 Oct 2025
- 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 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Phase 1 Study to Characterize the Effects of Belzutifan on the Pharmacokinetics of a MATE1/2K Substrate, Metformin, in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07121959
- Acronym / sponsor ID
- 6482-039
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 13 Sep 2025 (actual)
- Study completion
- 26 Sep 2025 (actual)
- First posted
- 14 Aug 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 this study is to learn how belzutifan (MK-6482) affects the levels of metformin in a healthy person's body over time. Researchers will study levels of metformin in the blood and urine in healthy volunteers after taking metformin alone (Period 1) and metformin with belzutifan (Period 2).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin | Experimental | Drug: MetforminOn Day 1 of Period 1, a single dose of metformin will be administered. |
| Belzutifan with Metformin | Experimental | Drug: Metformin, Drug: BelzutifanIn Period 2, belzutifan will be administered every day for 5 consecutive days with a single dose of metformin coadministered on Day 4. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| MetforminAlso: Metformin HClOral Tablet | Drug | Belzutifan with Metformin, Metformin |
| BelzutifanAlso: MK-6482Oral Tablet | Drug | Belzutifan with Metformin |
Primary outcome
Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) for Metformin in Plasma
Time frame: At designated timepoints (up to approximately 48 hours post-dose metformin)
Blood samples will be collected to determine the AUC0-inf of metformin in plasma.
13 secondary outcomes
Number of Participants Who Experience One or More Adverse Events (AEs)
Time frame: Up to approximately 4 weeks
Number of Participants Who Discontinue Study Drug Due to an AE
Time frame: Up to approximately 2 weeks
Area Under the Concentration Versus Time Curve from 0 to the Last Quantifiable Sample (AUC0-last) of Metformin
Time frame: At designated timepoints (up to approximately 48 hours post-dose metformin)
Area Under the Concentration Versus Time Curve from 0 to 24 hours (AUC0-24) of Metformin
Time frame: At designated timepoints (up to approximately 24 hours post-dose metformin)
Maximum Observed Concentration (Cmax) of Metformin
Time frame: At designated timepoints (up to approximately 48 hours post-dose metformin)
Plasma Drug Concentration of Metformin at Hour 24 (C24)
Time frame: 24 hours post-dose metformin
Time to Maximum Concentration (Tmax) of Metformin
Time frame: At designated timepoints (up to approximately 48 hours post-dose metformin)
Apparent Terminal Half-life (t1/2) of Metformin
Time frame: At designated timepoints (up to approximately 48 hours post-dose metformin)
Apparent Clearance (CL/F) of Metformin
Time frame: At designated timepoints (up to approximately 48 hours post-dose metformin)
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Metformin
Time frame: At designated timepoints (up to approximately 48 hours post-dose metformin)
Total Amount of Metformin Excreted Unchanged in the Urine
Time frame: At designated timepoints (up to approximately 48 hours post-dose metformin)
Percentage of Metformin Excreted Unchanged in Urine
Time frame: At designated timepoints (up to approximately 48 hours post-dose metformin)
Renal Clearance of Metformin
Time frame: At designated timepoints (up to approximately 48 hours post-dose metformin)
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 15 Oct 2025.
- 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. 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 Metformin and Belzutifan 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?
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 15 Oct 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 Versus Time Curve From Time Zero to Infinity (AUC0-inf) for Metformin in Plasma (time frame: At designated timepoints (up to approximately 48 hours post-dose metformin)). 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 15 Oct 2025.