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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Belzutifan; Drug: Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT07121959

MK-6482-039 (Other Identifier)

6482-039

Details and patient eligibility

About

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).

Enrollment: 14 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Metformin

Experimental group

Description:

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

Treatment:

Drug: Metformin

Belzutifan with Metformin

Experimental group

Description:

In Period 2, belzutifan will be administered every day for 5 consecutive days with a single dose of metformin coadministered on Day 4.

Treatment:

Drug: Metformin

Drug: Belzutifan