Healthy Participants
Conditions
Brief summary
The main purpose of this study is to determine the effect of vimseltinib on pharmacokinetics of combined oral contraceptive (COC) (ethinyl estradiol/levonorgestrel) in healthy female participants. This study will last approximately 35 days.
Interventions
DRUGVimseltinib
Administered orally
DRUGCombined Oral Contraceptive (COC) (ethinyl estradiol [EE]/levonorgestrel [LNG])
Administered orally
Sponsors
Deciphera Pharmaceuticals, LLC
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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 (≥) 18.5 to less than or equal to ≤ 30 kilogram per square meter (kg/m\^2). 3. Adequate organ function, 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK): Maximum Observed Plasma Drug Concentration (Cmax) of EE and LNG | Predose up to 72 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 EE and LNG | Predose up to 72 Hours Post Dose |
| PK: AUC from Time 0 to Infinity (AUC0-∞) of EE and LNG | Predose up to 72 Hours Post Dose |
Secondary
| Measure | Time frame |
|---|---|
| PK: Apparent Systemic Clearance (CL/F) of EE and LNG | Predose up to 72 Hours Post Dose |
| PK: Apparent Volume of Distribution Associated with the Terminal Phase (Vz/F) of EE and LNG | Predose up to 72 Hours Post Dose |
| PK: Time to Maximum Observed Plasma Concentration (Tmax) of EE and LNG | Predose up to 72 Hours Post Dose |
| PK: Terminal Elimination Phase Half-Life (t1/2) of EE and LNG | Predose up to 72 Hours Post Dose |
| Safety: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Baseline through Day 35 |
| Safety: Number of Participants with Clinically Significant Change from Baseline in Clinical Laboratory Parameters | Baseline through Day 21 |
| Safety: Number of Participants with Clinically Significant Change from Baseline in Vital Signs | Baseline through Day 21 |
Countries
United States
Contacts
CONTACTClinical Team
STUDY_DIRECTORClinical Team
Deciphera Pharmaceuticals, LLC
Outcome results
None listed