Recruiting
Phase 1

Vimseltinib with Dabigatran

Sponsor:

Deciphera Pharmaceuticals, LLC

Code:

NCT07744802

Conditions

Healthy Male Participants

Eligibility Criteria

Sex: Male

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Vimseltinib

Dabigatran

Study Details

Brief summary:

The main purpose of this study is to determine the effect of vimseltinib on pharmacokinetics of P-glycoprotein (P-gp) substrate (dabigatran) in healthy male participants. This study will last approximately 21 days.

Conditions

Healthy Male Participants

Study ID

NCT07744802

Start date

Sep, 2026

Status verified date

Sep, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 55

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Participants are in good general health, as required by the protocol and as determined by Principal Investigator.
2. Body mass index (BMI) from greater than or equal to (≥) 18 to less than or equal to ≤ 32 kilogram per square meter (kg/m\^2).
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 or history or presence of clinically significant psychiatric, immunological, endocrine, or metabolic disease as determined by Principal 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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Vimseltinib + Dabigatran

Day 1 single dose of dabigatran, and Day 5 coadministration of dabigatran with vimseltinib.

Interventions

Vimseltinib

Administered orally

Dabigatran

Administered orally

Primary outcome measure

  • Pharmacokinetics (PK): Maximum Observed Plasma Drug Concentration (Cmax) of Dabigatran [ Time Frame: Predose up to 48 Hours Post Dose ]
  • PK: Area Under the Plasma Concentration-Time Curve from Time 0 up to Time t (AUC0-t), Where t is the Last Time Point at Which the Concentration is Above the Lower Limit of Quantification of Dabigatran [ Time Frame: Predose up to 48 Hours Post Dose ]
  • PK: AUC from Time 0 to Infinity (AUC0-∞) of Dabigatran [ Time Frame: Predose up to 48 Hours Post Dose ]

Central Contacts and Locations

Central contacts

Clinical Team

888-724-3274clinicaltrials@deciphera.com

Locations

Dr. Vince Clinical Research

Recruiting

Overland Park, Kansas, United States, 66212

Contacts

913-333-3000

Principal Investigator:

Benjamin T Sundling, D.O.

More Information

Sponsor

Deciphera Pharmaceuticals, LLC

Last update posted

Sep 25, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Deciphera Pharmaceuticals, LLC on 2026-09-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.