Evaluate the Effect of Vimseltinib on P-glycoprotein (P-gp) Inhibition in Healthy Male Participants

A Phase 1, Open-label, Fixed-sequence Study to Evaluate the Effect of Vimseltinib on P-glycoprotein (P-gp) Inhibition in Healthy Male Participants

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07744802

Enrollment

Registered

2026-08-04

Start date

2026-09-01

Completion date

2026-12-01

Last updated

2026-09-02

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

Conditions

Healthy Male Participants

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.

Interventions

DRUGVimseltinib

Administered orally

DRUGDabigatran

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. 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.

Design outcomes

Primary

Measure	Time frame
PK: AUC from Time 0 to Infinity (AUC0-∞) of Dabigatran	Predose up to 48 Hours Post Dose
Pharmacokinetics (PK): Maximum Observed Plasma Drug Concentration (Cmax) of Dabigatran	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	Predose up to 48 Hours Post Dose

Secondary

Measure	Time frame
Safety: Number of Participants with Clinically Significant Change from Baseline in Clinical Laboratory Parameters	Baseline through Day 21
Safety: Number of Participants with Clinically Significant Change from Baseline in Vital Signs	Baseline through Day 21
PK: Apparent Systemic Clearance (CL/F) of Dabigatran	Predose up to 48 Hours Post Dose
PK: Time to Maximum Observed Plasma Concentration (Tmax) of Dabigatran	Predose up to 48 Hours Post Dose
PK: Apparent Volume of Distribution Associated with the Terminal Phase (Vz/F) of Dabigatran	Predose up to 48 Hours Post Dose
PK: Terminal Elimination Phase Half-Life (t1/2) of Dabigatran	Predose up to 48 Hours Post Dose
Safety: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Baseline through Day 21

Contacts

CONTACTClinical Team

clinicaltrials@deciphera.com888-724-3274

STUDY_DIRECTORClinical Team

Deciphera Pharmaceuticals, LLC

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 3, 2026