Vimseltinib’s effect on P-glycoprotein inhibition in healthy men
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
Run by Deciphera Pharmaceuticals, LLC · NCT07744802 · Data updated 2026-11-12
This study tests whether vimseltinib changes how a P-glycoprotein substrate (dabigatran) behaves in the body of healthy men.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 55 Years |
| Sex | Men only |
| Enrollment | 20 (estimated) |
| Sponsor | Deciphera Pharmaceuticals, LLC Industry-sponsored |
| Drugs / interventions | vimseltinib |
| Locations | 1 site (Overland Park, Kansas) |
| Status | Recruiting |
| Started | October 8, 2026 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | November 6, 2026 |
| Trial ID | NCT07744802 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adult men with BMI 18–32 kg/m2 and normal organ function.
✕Probably not a fit
Participants with significant medical conditions or inability to comply with protocol requirements may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This early-phase study investigates how vimseltinib affects the pharmacokinetics of a P-gp substrate (dabigatran) in healthy male volunteers. It is a 21-day, interventional trial that co-administers vimseltinib and dabigatran to observe drug interactions. The trial will assess safety, tolerability, and how the drugs interact at the body’s absorption, distribution, metabolism, and excretion levels. Participants must be generally healthy, within specific BMI and lab criteria, and able to comply with study procedures. The study is led by Deciphera Pharmaceuticals with Dr. Vince Clinical Research in Overland Park, KS.
Why it matters
Potential benefit: If successful, results could clarify potential drug interactions with vimseltinib and guide safer use in patients who may take P-gp substrate medications.
How similar studies have gone: Previous studies with similar P-gp modulation approaches have shown measurable pharmacokinetic interactions, though this exact combination is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Dr. Vince Clinical Research
Overland Park, Kansas, United States Recruiting
Study contacts
- Study coordinator: Clinical Team
- Email: clinicaltrials@deciphera.com
- Phone: 888-724-3274
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.