Elenestinib for Healthy Subjects

Overseen By Blueprint Medicines

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Blueprint Medicines Corporation

Must not be taking: CYP3A4 inducers, SHBG modulators

Disqualifiers: Alcohol abuse, Drug abuse, Cannabis use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4-6 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for healthy adult women. Participants must be eligible to take oral contraceptives and willing to have blood samples taken. Specific details about inclusion and exclusion criteria are not provided, but typically these would cover age range, general health status, and no current medications or conditions that could interfere with the study.

Inclusion Criteria

I am a postmenopausal woman.

Continuous non-smoker for at least 6 months prior to the first dosing

BMI ≥ 18.0 and ≤ 35.0 kg/m2 at the screening visit

Exclusion Criteria

History or presence of hypersensitivity or idiosyncratic reaction to specific compounds

Unable to refrain from or anticipates the use of certain drugs

I don't have any health conditions that could affect the study's results or increase my risk.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive midazolam and levonorgestrel/ethinyl estradiol with and without elenestinib and have blood samples taken

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Elenestinib

Trial Overview

The study is testing how elenestinib affects the body's handling of midazolam (a sedative) and a combined oral contraceptive (levonorgestrel/ethinyl estradiol). Women will take these drugs with and without elenestinib to compare differences in drug levels in their blood.

How Is the Trial Designed?

Group I: Elenestinib, Midazolam, and Levonorgestrel/Ethinyl Estradiol Experimental Treatment 3 Interventions

Who Is Running the Clinical Trial?

Blueprint Medicines Corporation

Lead Sponsor

Trials

31

Recruited

6,000+