A Study of Belzutifan (MK-6482) and Metformin in Healthy Adult Participants (MK-6482-039)

Not Applicable

Not yet recruiting

• Conditions: Healthy
• Interventions: Drug: Metformin; Drug: Belzutifan

• Registration Number: NCT07121959
• Lead Sponsor: Merck Sharp & Dohme LLC

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-12
• Study First Submitted QC: 2025-08-12
• Last Update Submitted: 2025-08-12
• Study First Posted: 2025-08-14
• Last Update Posted: 2025-08-14
• Study Start: 2025-08-18
• Primary Completion: 2025-09-13
• Study Completion: 2025-09-26

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Metformin	Metformin	On Day 1 of Period 1, a single dose of metformin will be administered.
Belzutifan with Metformin	Metformin	In Period 2, belzutifan will be administered every day for 5 consecutive days with a single dose of metformin coadministered on Day 4.
Belzutifan with Metformin	Belzutifan	In Period 2, belzutifan will be administered every day for 5 consecutive days with a single dose of metformin coadministered on Day 4.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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 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.
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.
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.
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.
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.
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.
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.