Healthy Participants
Conditions
Brief summary
The main objectives of this study are to determine the effect of elenestinib on the pharmacokinetic parameters (how the drug is absorbed, distributed, and processed by the body) of midazolam, and to determine the effect of elenestinib on the pharmacokinetic parameters of levonorgestrel/ethinyl estradiol, when given as a combined oral contraceptive. Healthy adult participants will receive midazolam and levonorgestrel/ethinyl estradiol with and without elenestinib and have blood samples taken.
Interventions
DRUGElenestinib
Specified dose on specified days
DRUGMidazolam
Specified dose on specified days
Specified dose on specified days
Sponsors
Blueprint Medicines Corporation
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * Healthy, adult, female, 18-65 years of age, inclusive, at the screening visit that meet either of the following criteria: * Postmenopausal female, defined as amenorrhea for at least 1 year prior to the first dosing and follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status at the screening visit (note that participants may have had hysterectomy, bilateral salpingectomy, or bilateral tubal ligation). * Female status-post bilateral oophorectomy. * Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 6 months prior to the first dosing. * BMI ≥ 18.0 and ≤ 35.0 kg/m2 at the screening visit. * Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and electrocardiograms (ECGs), as deemed by the principal investigator (PI) or designee. Key
Exclusion criteria
* History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee. * History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study. * History or presence of alcohol or drug abuse (except for the occasional use of cannabis products) within the past 1 years prior to the first dosing. * History or presence of cannabis use within the past 3 months prior to the first dosing. * History or presence of hypersensitivity or idiosyncratic reaction to elenestinib, midazolam, combined oral contraceptive (levonorgestrel/ethinyl estradiol), or related compounds. * Unable to refrain from or anticipates the use of: * Any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing. * Any drugs known to be moderate or strong inducers of CYP3A4 enzymes and/or P-gp beginning at least 28 days prior to first dosing. * Any drugs known to increase or decrease levels of SHBG, including any oral, topical, or intravaginal hormone-containing product, within 12 weeks prior to the first dosing. Other protocol-defined inclusion and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (AUC0-t) | Up to 27 days |
| Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) | Up to 27 days |
| Percent of AUC0-inf extrapolated (AUC%extrap) | Up to 27 days |
| Maximum observed concentration (Cmax) | Up to 27 days |
| Time to reach Cmax (Tmax) | Up to 27 days |
| Apparent first-order terminal elimination half-life (t1/2) | Up to 27 days |
| Apparent total plasma clearance after oral administration (CL/F) | Up to 27 days |
| Apparent volume of distribution during the terminal elimination phase after oral administration (Vz/F) | Up to 27 days |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with treatment-emergent adverse events (TEAEs) | From first dose to date of last dose plus 30 days (up to approximately 7 weeks) |
Countries
United States
Outcome results
None listed