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

Deciphera Pharmaceuticals, LLC22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Participants

Interventions

VimseltinibDRUG

Administered orally

MetforminDRUG

Administered orally

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Dr. Vince Clinical Research

Overland Park, Kansas, United States

Outcomes

Primary Outcomes

Pharmacokinetic (PK): Maximum Observed Plasma Drug Concentration (Cmax) of Metformin

Time frame: Predose up to 48 hours postdose

PK: Area Under the Concentration Versus Time Curve (AUC) of Metformin

Time frame: Predose up to 48 hours postdose

Secondary Outcomes

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Time frame: Baseline through Day 25

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.