NCT07388511

A Study of Elenestinib in Healthy Adult Female Participants

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Blueprint Medicines Corporation · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Elenestinib	Specified dose on specified days
DRUG	Midazolam	Specified dose on specified days
DRUG	Levonorgestrel/Ethinyl Estradiol	Specified dose on specified days

Timeline

• Start date: 2026-02-03
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2026-02-05
• Last updated: 2026-02-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study