A Study of Elenestinib in Healthy Adult Female Participants

April 17, 2026 updated by: Blueprint Medicines Corporation

A Phase 1, Open-Label Study to Evaluate the Effect of Elenestinib on the Pharmacokinetics of Midazolam and Combined Oral Contraceptives, Levonorgestrel/Ethinyl Estradiol, in Healthy Adult Female Participants

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tempe, Arizona, United States, 85282
        • Celerion, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Elenestinib, Midazolam, and Levonorgestrel/Ethinyl Estradiol
Drug: Midazolam
Specified dose on specified days
Drug: Elenestinib
Specified dose on specified days
Drug: Levonorgestrel/Ethinyl Estradiol
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (AUC0-t)
Time Frame: Up to 27 days
Up to 27 days
Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf)
Time Frame: Up to 27 days
Up to 27 days
Percent of AUC0-inf extrapolated (AUC%extrap)
Time Frame: Up to 27 days
Up to 27 days
Maximum observed concentration (Cmax)
Time Frame: Up to 27 days
Up to 27 days
Time to reach Cmax (Tmax)
Time Frame: Up to 27 days
Up to 27 days
Apparent first-order terminal elimination half-life (t1/2)
Time Frame: Up to 27 days
Up to 27 days
Apparent total plasma clearance after oral administration (CL/F)
Time Frame: Up to 27 days
Up to 27 days
Apparent volume of distribution during the terminal elimination phase after oral administration (Vz/F)
Time Frame: Up to 27 days
Up to 27 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with treatment-emergent adverse events (TEAEs)
Time Frame: From first dose to date of last dose plus 30 days (up to approximately 7 weeks)
From first dose to date of last dose plus 30 days (up to approximately 7 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Blueprint Medicines Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2026

Primary Completion (Actual)

April 2, 2026

Study Completion (Actual)

April 2, 2026

Study Registration Dates

First Submitted

January 29, 2026

First Submitted That Met QC Criteria

January 29, 2026

First Posted (Actual)

February 5, 2026

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BLU-263-0104

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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