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Completed

NCT Number: NCT07121959

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

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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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion ( Site 0001)

Tempe, Arizona, 85283, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metformin

Drug

Oral Tablet

Other names: Metformin HCl

Belzutifan

Drug

Oral Tablet

Other names: MK-6482

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: 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.

  2. Number of Participants Who Discontinue Study Drug Due to an AE

    Time frame: 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.

  3. 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)

    Plasma samples will be collected to determine the AUC0-last of metformin.

  4. 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)

    Plasma samples will be collected to determine the AUC0-24 of metformin.

  5. Maximum Observed Concentration (Cmax) of Metformin

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

    Plasma samples will be collected to determine the Cmax of metformin.

  6. Plasma Drug Concentration of Metformin at Hour 24 (C24)

    Time frame: 24 hours post-dose metformin

    Plasma samples will be collected to determine the C24 of metformin.

  7. Time to Maximum Concentration (Tmax) of Metformin

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

    Plasma samples will be collected to determine the Tmax of metformin.

  8. Apparent Terminal Half-life (t1/2) of Metformin

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

    Plasma samples will be collected to determine the t1/2 of metformin.

  9. Apparent Clearance (CL/F) of Metformin

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

    Plasma samples will be collected to determine the CL/F of metformin.

  10. Apparent Volume of Distribution During Terminal Phase (Vz/F) of Metformin

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

    Plasma samples will be collected to determine the Vz/F of metformin.

  11. Total Amount of Metformin Excreted Unchanged in the Urine

    Time frame: 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.

  12. Percentage of Metformin Excreted Unchanged in Urine

    Time frame: 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.

  13. Renal Clearance of Metformin

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

    Urine samples will be collected to determine the renal clearance of metformin.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 14, 2025
Registry last updated
Oct 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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