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

NCT07744802 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: DCC-3014-01-009
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (3)

• 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

• PK: AUC from Time 0 to Infinity (AUC0-∞) of Dabigatran

  Predose up to 48 Hours Post Dose

Secondary Outcomes (7)

• Safety: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  Baseline through Day 21

• 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: Apparent Volume of Distribution Associated with the Terminal Phase (Vz/F) of Dabigatran

  Predose up to 48 Hours Post Dose

Study Arms (1)

Vimseltinib + Dabigatran

EXPERIMENTAL

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

Drug: Vimseltinib; Drug: Dabigatran

Interventions

Vimseltinib DRUG

Administered orally

Vimseltinib + Dabigatran

Dabigatran DRUG

Administered orally

Vimseltinib + Dabigatran

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants are in good general health, as required by the protocol and as determined by Principal Investigator.
• 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).
• 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 or history or presence of clinically significant psychiatric, immunological, endocrine, or metabolic disease as determined by Principal 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

MeSH Terms

Interventions

Dabigatran

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Clinical Team

  Deciphera Pharmaceuticals, LLC

  STUDY DIRECTOR

Central Study Contacts

Clinical Team

CONTACT

888-724-3274; clinicaltrials@deciphera.com

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: July 30, 2026
• First Posted: August 4, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share