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

A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Effect of Vimseltinib on Organic Cation Transporter 2 (OCT2) Inhibition in Healthy Male Participants

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07158411

Enrollment

Registered

2025-09-05

Start date

2025-11-20

Completion date

2026-01-30

Last updated

2026-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

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.

Interventions

DRUGVimseltinib

Administered orally

DRUGMetformin

Administered orally

Study design

Allocation

Intervention model

SEQUENTIAL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Baseline through Day 25

Countries

United States

Contacts

STUDY_DIRECTORClinical Team

Deciphera Pharmaceuticals, LLC

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026