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| ID | Type | Description | Link |
|---|---|---|---|
| MK-6482-039 | Other Identifier | MSD |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin | Experimental | On Day 1 of Period 1, a single dose of metformin will be administered. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Oral Tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | At designated timepoints (up to approximately 48 hours post-dose metformin) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to approximately 4 weeks |
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The main inclusion criteria include, but are not limited to:
The main exclusion criteria include, but are not limited to:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion ( Site 0001) | Tempe | Arizona | 85283 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| C000720612 | belzutifan |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Belzutifan | Drug | Oral Tablet |
|
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| 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. | 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. | 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. | 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. | 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. | 24 hours post-dose metformin |
| Time to Maximum Concentration (Tmax) of Metformin | Plasma samples will be collected to determine the Tmax of metformin. | 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. | 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. | 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. | 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. | 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. | 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. | At designated timepoints (up to approximately 48 hours post-dose metformin) |