Evaluate the Effect of Vimseltinib on P-glycoprotein (P-gp) Inhibition in Healthy Male Participants | NCT07744802

NCT07744802

Overview

NCT ID: NCT07744802
Lead Sponsor: Deciphera Pharmaceuticals, LLCINDUSTRY
Official Title: A Phase 1, Open-label, Fixed-sequence Study to Evaluate the Effect of Vimseltinib on P-glycoprotein (P-gp) Inhibition in 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.
Conditions: Healthy Male Participants
Interventions: Vimseltinib
Dabigatran

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Aug 4, 2026Actual
Start Date: Aug 2026Estimated
Primary Completion Date: Nov 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: Male
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

Study Type: Interventional
Phase: Phase 1
Enrollment: 20Estimated
Primary Purpose: Basic Science
Allocation: N/A
Interventional Model: Sequential Assignment
Masking

Contacts and Locations

Central Contacts: Clinical TeamContact
clinicaltrials@deciphera.com

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