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

NCT07121959 | Completed Phase 1 FDA Drug

• 2 other identifiers: 6482-039MK-6482-039
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (13)

• Number of Participants Who Experience One or More Adverse Events (AEs)

  Up to approximately 4 weeks

• Number of Participants Who Discontinue Study Drug Due to an AE

  Up to approximately 2 weeks

• 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)

• 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)

• Maximum Observed Concentration (Cmax) of Metformin

  At designated timepoints (up to approximately 48 hours post-dose metformin)

Study Arms (2)

Metformin

EXPERIMENTAL

On Day 1 of Period 1, a single dose of metformin will be administered.

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.

Drug: Metformin; Drug: Belzutifan

Interventions

Metformin DRUG

Oral Tablet

Also known as: Metformin HCl

Belzutifan with Metformin; Metformin

Belzutifan DRUG

Oral Tablet

Also known as: MK-6482

Belzutifan with Metformin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Celerion ( Site 0001)

Tempe, Arizona, 85283, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

Metformin; belzutifan

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 14, 2025
• Study Start: August 18, 2025
• Primary Completion: September 13, 2025
• Study Completion: September 26, 2025
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)