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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNovartis Pharmaceuticals

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 treatment options are available.

Eligibility criteria

Qualifiers

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

Platelet count ≥ 150 × 109 /L in the absence of thrombopoietic factors or transfusions within 2 weeks of the screening assessment

Absolute neutrophil count (ANC) ≥ 1 × 109 /L in the absence of granulocyte growth factors

Disqualifiers

Has a history of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical class.

Is pregnant (confirmed by a pregnancy test at screening) or is breastfeeding.

Has current known active or chronic infection with HIV, hepatitis B, or hepatitis C.

Has impaired cardiac function or clinically significant cardiac disease.

Trial design

Treatments tested in this trial

  • pelabresib
  • repaglinide
  • midazolam
  • drospirenone
  • ethinyl estradiol

Treatment groups

24 Participants
are divided into 2 treatment groups

Sponsors and collaborators