A Study of Elenestinib in Healthy Adult Female Participants

NCT07388511 | Completed Phase 1 FDA Drug

• 1 other identifier: BLU-263-0104
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• 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)

Study Arms (1)

Elenestinib, Midazolam, and Levonorgestrel/Ethinyl Estradiol

EXPERIMENTAL

Drug: Elenestinib; Drug: Midazolam; Drug: Levonorgestrel/Ethinyl Estradiol

Interventions

Levonorgestrel/Ethinyl Estradiol DRUG

Specified dose on specified days

Elenestinib, Midazolam, and Levonorgestrel/Ethinyl Estradiol

Elenestinib DRUG

Specified dose on specified days

Elenestinib, Midazolam, and Levonorgestrel/Ethinyl Estradiol

Midazolam DRUG

Specified dose on specified days

Elenestinib, Midazolam, and Levonorgestrel/Ethinyl Estradiol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Blueprint Medicines Corporation: lead

Study Sites (1)

Celerion, Inc

Tempe, Arizona, 85282, United States

Location

MeSH Terms

Interventions

Midazolam; Ethinyl Estradiol-Norgestrel Combination

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ethinyl Estradiol; Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Norgestrel; Norpregnenes; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 5, 2026
• Study Start: February 5, 2026
• Primary Completion: April 2, 2026
• Study Completion: April 2, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

US (1)