Healthy ParticipantsPhase 1NCT07388511
A Study of Elenestinib in Healthy Adult Female Participants
A Phase 1 study testing Elenestinib, Midazolam and Levonorgestrel/Ethinyl Estradiol in people with Healthy Participants, run by Blueprint Medicines Corporation at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Elenestinib, Midazolam and Levonorgestrel/Ethinyl Estradiol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2026to 2 Apr 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy Participants
- Being tested
- Elenestinib, Midazolam, Levonorgestrel/Ethinyl Estradiol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElenestinibDrug
Specified dose on specified days
MidazolamDrug
Specified dose on specified days
Levonorgestrel/Ethinyl EstradiolDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Elenestinib, Midazolam, and Levonorgestrel/Ethinyl Estradiol | Experimental | Not described Receives: Drug: Elenestinib; Drug: Midazolam; Drug: Levonorgestrel/Ethinyl Estradiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (AUC0-t)
Measured: Up to 27 days
Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf)
Measured: Up to 27 days
Percent of AUC0-inf extrapolated (AUC%extrap)
Measured: Up to 27 days
Maximum observed concentration (Cmax)
Measured: Up to 27 days
Time to reach Cmax (Tmax)
Measured: Up to 27 days
Apparent first-order terminal elimination half-life (t1/2)
Measured: Up to 27 days
Apparent total plasma clearance after oral administration (CL/F)
Measured: Up to 27 days
Apparent volume of distribution during the terminal elimination phase after oral administration (Vz/F)
Measured: Up to 27 days
Secondary outcomes (1)
Number of participants with treatment-emergent adverse events (TEAEs)
Measured: From first dose to date of last dose plus 30 days (up to approximately 7 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start5 Feb 2026
- Primary completion2 Apr 2026
- Study completion2 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Blueprint Medicines Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07388511
- Sponsor's protocol ID
- BLU-263-0104
- Status last verified
- Apr 2026
- First submitted
- 29 Jan 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07388511
- Acronym / sponsor ID
- BLU-263-0104
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Blueprint Medicines CorporationIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- 2 Apr 2026 (actual)
- Study completion
- 2 Apr 2026 (actual)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elenestinib, Midazolam, and Levonorgestrel/Ethinyl Estradiol | Experimental | Drug: Elenestinib, Drug: Midazolam, Drug: Levonorgestrel/Ethinyl Estradiol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElenestinibSpecified dose on specified days | Drug | Elenestinib, Midazolam, and Levonorgestrel/Ethinyl Estradiol |
| MidazolamSpecified dose on specified days | Drug | Elenestinib, Midazolam, and Levonorgestrel/Ethinyl Estradiol |
| Levonorgestrel/Ethinyl EstradiolSpecified dose on specified days | Drug | Elenestinib, Midazolam, and Levonorgestrel/Ethinyl Estradiol |
Primary outcome
Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (AUC0-t)
Time frame: Up to 27 days
Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf)
Time frame: Up to 27 days
Percent of AUC0-inf extrapolated (AUC%extrap)
Time frame: Up to 27 days
Maximum observed concentration (Cmax)
Time frame: Up to 27 days
Time to reach Cmax (Tmax)
Time frame: Up to 27 days
Apparent first-order terminal elimination half-life (t1/2)
Time frame: Up to 27 days
Apparent total plasma clearance after oral administration (CL/F)
Time frame: Up to 27 days
Apparent volume of distribution during the terminal elimination phase after oral administration (Vz/F)
Time frame: Up to 27 days
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Elenestinib, Midazolam and Levonorgestrel/Ethinyl Estradiol in people with Healthy Participants, run by Blueprint Medicines Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (AUC0-t) (time frame: Up to 27 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.