Not yet recruiting NCT07744802
Evaluate the Effect of Vimseltinib on P-glycoprotein (P-gp) Inhibition in Healthy Male Participants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vimseltinib, Dabigatran.
- Who it may be relevant to
- Registry conditions: Healthy Male Participants. Basic parameters: 18 years — 55 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
- Drug Vimseltinib
Administered orally - Drug Dabigatran
Administered orally
Primary outcome measures
- 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]
Secondary outcome measures (7)
- 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07744802 · DCC-3014-01-009