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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-55
SponsorDeciphera Pharmaceuticals, LLC

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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/m²).

Adequate organ function and blood and urine tests, as required by the protocol and as determined by Principal Investigator.

Disqualifiers

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 design

Design model

Sequential

Treatments tested in this trial

  • Vimseltinib

    Drug

    Administered orally

  • Dabigatran

    Drug

    Administered orally

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Vimseltinib + DabigatranExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Pharmacokinetics (PK): Maximum Observed Plasma Drug Concentration (Cmax) of Dabigatran

Time frame
Predose up to 48 Hours Post Dose
2

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
3

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

Time frame
Predose up to 48 Hours Post Dose

Secondary outcomes

1

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

Time frame
Baseline through Day 21
2

Safety: Number of Participants with Clinically Significant Change from Baseline in Clinical Laboratory Parameters

Time frame
Baseline through Day 21
3

Safety: Number of Participants with Clinically Significant Change from Baseline in Vital Signs

Time frame
Baseline through Day 21
4

PK: Apparent Systemic Clearance (CL/F) of Dabigatran

Time frame
Predose up to 48 Hours Post Dose

Other outcomes

Sponsors and contacts

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