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
Recruiting
Phase 1
Interventional Study
Advanced Malignancies
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 24 (estimated)
- Sponsor
- Novartis Pharmaceuticals · Industry
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria:
Key inclusion criteria for all participants (Arm A and Arm B)
* Is at least 18 years of age at the time of signing the informed consent.
* Has a confirmed documented diagnosis of an advanced malignancy for which no standard and/or curative treatment options are available
* …
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