Healthy
Conditions
Brief 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).
Interventions
DRUGMetformin
Oral Tablet
DRUGBelzutifan
Oral Tablet
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) for Metformin in Plasma | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Discontinue Study Drug Due to an AE | Up to approximately 2 weeks | 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. |
| Area Under the Concentration Versus Time Curve from 0 to the Last Quantifiable Sample (AUC0-last) of Metformin | At designated timepoints (up to approximately 48 hours post-dose metformin) | Plasma samples will be collected to determine the AUC0-last of metformin. |
| Area Under the Concentration Versus Time Curve from 0 to 24 hours (AUC0-24) of Metformin | At designated timepoints (up to approximately 24 hours post-dose metformin) | Plasma samples will be collected to determine the AUC0-24 of metformin. |
| Maximum Observed Concentration (Cmax) of Metformin | At designated timepoints (up to approximately 48 hours post-dose metformin) | Plasma samples will be collected to determine the Cmax of metformin. |
| Plasma Drug Concentration of Metformin at Hour 24 (C24) | 24 hours post-dose metformin | Plasma samples will be collected to determine the C24 of metformin. |
| Time to Maximum Concentration (Tmax) of Metformin | At designated timepoints (up to approximately 48 hours post-dose metformin) | Plasma samples will be collected to determine the Tmax of metformin. |
| Number of Participants Who Experience One or More Adverse Events (AEs) | Up to approximately 4 weeks | 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. |
| Apparent Clearance (CL/F) of Metformin | At designated timepoints (up to approximately 48 hours post-dose metformin) | Plasma samples will be collected to determine the CL/F of metformin. |
| Apparent Volume of Distribution During Terminal Phase (Vz/F) of Metformin | At designated timepoints (up to approximately 48 hours post-dose metformin) | Plasma samples will be collected to determine the Vz/F of metformin. |
| Total Amount of Metformin Excreted Unchanged in the Urine | At designated timepoints (up to approximately 48 hours post-dose metformin) | Urine samples will be collected to determine the total amount of metformin excreted unchanged in the urine. |
| Percentage of Metformin Excreted Unchanged in Urine | At designated timepoints (up to approximately 48 hours post-dose metformin) | Urine samples will be collected to determine the percentage of metformin excreted unchanged in urine. |
| Renal Clearance of Metformin | At designated timepoints (up to approximately 48 hours post-dose metformin) | Urine samples will be collected to determine the renal clearance of metformin. |
| Apparent Terminal Half-life (t1/2) of Metformin | At designated timepoints (up to approximately 48 hours post-dose metformin) | Plasma samples will be collected to determine the t1/2 of metformin. |
Countries
United States
Outcome results
None listed