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.
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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 * …
Contacts

Novartis Pharmaceuticals

+41613241111

novartis.email@novartis.com

CONTACT

Novartis Pharmaceuticals

novartis.email@novartis.com

CONTACT