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

NCT07158411 | Completed Phase 1 FDA Drug

• 1 other identifier: DCC-3014-01-008
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (2)

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

  Predose up to 48 hours postdose

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

  Predose up to 48 hours postdose

Secondary Outcomes (1)

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

  Baseline through Day 25

Study Arms (1)

Metformin + Vimseltinib

EXPERIMENTAL

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

Drug: Vimseltinib; Drug: Metformin

Interventions

Metformin DRUG

Administered orally

Metformin + Vimseltinib

Vimseltinib DRUG

Administered orally

Metformin + Vimseltinib

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.
• Unwilling or unable to comply with the requirements of the protocol.
• Determined by Principal Investigator to be unsuitable to participate in the study for any other reason.

Sponsors & Collaborators

• Deciphera Pharmaceuticals, LLC: lead

Study Sites (1)

Dr. Vince Clinical Research

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Clinical Team

  Deciphera Pharmaceuticals, LLC

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 5, 2025
• Study Start: November 20, 2025
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)