drugset / Trial / NCT07340190
A Drug-drug Interaction Study to Evaluate the Effects of Pelabresib on the Pharmacokinetics of Repaglinide, Midazolam, and Combined Oral Contraceptive in Patients With Advanced Malignancies
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This drug-drug interaction (DDI) study aims to evaluate the impact of pelabresib at steady-state plasma concentrations on the pharmacokinetic (PK) profile of A) a single dose of repaglinide and a single dose of midazolam, and B) a single dose of combined drospirenone and ethinyl estradiol. The study will be conducted in adult participants with advanced malignancies for whom no standard or curative treatment options are available.
Timeline
- Start
- 2026-06-12
- Primary completion
- 2028-03-09
- Completion
- 2028-04-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Midazolam | Small molecule | 2 mg/ml | Oral |
| Subject | Pelabresib | Small molecule | 225 mg | Oral |
| Subject | Repaglinide | Small molecule | 0.5 mg | Oral |
| Subject | drospirenone | Unknown | 3 mg | Oral |
| Subject | ethinyl estradiol | Small molecule | 0.03 mg | Oral |