Healthy Male ParticipantsPhase 1NCT07744802
Evaluate the Effect of Vimseltinib on P-glycoprotein (P-gp) Inhibition in Healthy Male Participants
A Phase 1 study testing Vimseltinib and Dabigatran in people with Healthy Male Participants, run by Deciphera Pharmaceuticals, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Participants
- What is being tested?
- Vimseltinib and Dabigatran
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dr. Vince Clinical Research
Overland Park, Kansas, 66212
913-333-3000
Benjamin T Sundling, D.O.
About this study
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
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
- Being tested
- Vimseltinib, Dabigatran
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VimseltinibDrug
Administered orally
DabigatranDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Vimseltinib + Dabigatran | Experimental | Day 1 single dose of dabigatran, and Day 5 coadministration of dabigatran with vimseltinib. Receives: Drug: Vimseltinib; Drug: Dabigatran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Maximum Observed Plasma Drug Concentration (Cmax) of Dabigatran
Measured: 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
Measured: Predose up to 48 Hours Post Dose
PK: AUC from Time 0 to Infinity (AUC0-∞) of Dabigatran
Measured: 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)
Measured: Baseline through Day 21
Safety: Number of Participants with Clinically Significant Change from Baseline in Clinical Laboratory Parameters
Measured: Baseline through Day 21
Safety: Number of Participants with Clinically Significant Change from Baseline in Vital Signs
Measured: Baseline through Day 21
PK: Apparent Systemic Clearance (CL/F) of Dabigatran
Measured: Predose up to 48 Hours Post Dose
PK: Apparent Volume of Distribution Associated with the Terminal Phase (Vz/F) of Dabigatran
Measured: Predose up to 48 Hours Post Dose
PK: Time to Maximum Observed Plasma Concentration (Tmax) of Dabigatran
Measured: Predose up to 48 Hours Post Dose
PK: Terminal Elimination Phase Half-Life (t1/2) of Dabigatran
Measured: Predose up to 48 Hours Post Dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male ParticipantsStudies of the same condition, open and under way.
- More trials run by Deciphera Pharmaceuticals, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deciphera Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Team, Study director, Deciphera Pharmaceuticals, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07744802
- Sponsor's protocol ID
- DCC-3014-01-009
- Status last verified
- Sep 2026
- First submitted
- 30 Jul 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07744802
- Acronym / sponsor ID
- DCC-3014-01-009
- Conditions
- Healthy Male Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Deciphera Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vimseltinib + Dabigatran | Experimental | Drug: Vimseltinib, Drug: DabigatranDay 1 single dose of dabigatran, and Day 5 coadministration of dabigatran with vimseltinib. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VimseltinibAdministered orally | Drug | Vimseltinib + Dabigatran |
| DabigatranAdministered orally | Drug | Vimseltinib + Dabigatran |
Primary outcome
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
7 secondary outcomes
Safety: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Baseline through Day 21
Safety: Number of Participants with Clinically Significant Change from Baseline in Clinical Laboratory Parameters
Time frame: Baseline through Day 21
Safety: Number of Participants with Clinically Significant Change from Baseline in Vital Signs
Time frame: Baseline through Day 21
PK: Apparent Systemic Clearance (CL/F) of Dabigatran
Time frame: Predose up to 48 Hours Post Dose
PK: Apparent Volume of Distribution Associated with the Terminal Phase (Vz/F) of Dabigatran
Time frame: Predose up to 48 Hours Post Dose
PK: Time to Maximum Observed Plasma Concentration (Tmax) of Dabigatran
Time frame: Predose up to 48 Hours Post Dose
PK: Terminal Elimination Phase Half-Life (t1/2) of Dabigatran
Time frame: Predose up to 48 Hours Post Dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Team study director
Deciphera Pharmaceuticals, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vimseltinib and Dabigatran in people with Healthy Male Participants, run by Deciphera Pharmaceuticals, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Team (888-724-3274, clinicaltrials@deciphera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (PK): Maximum Observed Plasma Drug Concentration (Cmax) of Dabigatran (time frame: Predose up to 48 Hours Post Dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.