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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
Conditions: Advanced Malignancies
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 24
Sponsor: Novartis Pharmaceuticals
Location: Novartis Investigative Site Candiolo TO
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.
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
* Has the following acceptable laboratory assessments prior to the first dose of study treatment:
1. Platelet count ≥ 150 × 109 /L in the absence of thrombopoietic factors or transfusions within 2 weeks of the screening assessment
2. Absolute neutrophil count (ANC) ≥ 1 × 109 /L in the absence of granulocyte growth factors
3. Peripheral blood blast count \< 5%. Assessment of blasts in bone marrow is not mandatory at screening; however, blasts must be \
Source: ClinicalTrials.gov (NCT07340190). StuddyBuddy aggregates publicly available trial information.