Evaluate the Effect of Vimseltinib on Organic Cation Transporter 2 (OCT2)

Deciphera Pharmaceuticals, LLC

Status and phase: Active, not recruiting; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Vimseltinib; Drug: Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT07158411

DCC-3014-01-008

Details and patient eligibility

About

The main purpose of this study is to evaluate the effect of multiple doses of vimseltinib on the pharmacokinetics (PK) of a clinical OCT2 substrate (metformin) in healthy male participants. This study will also assess the safety and tolerability when vimseltinib is co-administered with the clinical OCT2 substrate (metformin) in healthy male participants. This study will last approximately 25 days.

Enrollment: 20 estimated patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Body mass index (BMI) from 18 to 32 kilogram per square meter (kg/m^2).
2. Participants are in good general health, as required by the protocol and as determined by Principal Investigator.
3. Adequate organ function and blood and urine tests, as required by the protocol and as determined by Principal Investigator.

Exclusion criteria

1. History or presence of clinically significant diseases of the neurological, dermatological, renal, hepatic, gastrointestinal, cardiovascular, or musculoskeletal systems and/or history or presence of clinically significant psychiatric, immunological, endocrine, or metabolic disease in the opinion of the Investigator.
2. Unwilling or unable to comply with the requirements of the protocol.
3. Determined by Principal Investigator to be unsuitable to participate in the study for any other reason.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Metformin + Vimseltinib

Experimental group

Description:

Metformin as single dose will be administered on Day 1 and Day 6. Vimseltinib will be administered every day (QD) on Days 3 through 6

Treatment:

Drug: Metformin

Drug: Vimseltinib