Not Yet RecruitingPhase 1

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

24 participantsStarted 2026-05-29

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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
✓. Peripheral blood blast count \< 5%. Assessment of blasts in bone marrow is not mandatory at screening; however, blasts must be \<5% if the bone marrow assessment is performed.
✓. Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN)
✓. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN (≤5 × ULN if the elevation can be ascribed to liver involvement)
✓. Calculated or measured creatinine clearance of ≥30 mL/min\*

What they're measuring

Maximum Plasma Concentration (Cmax) of repaglinide, midazolam, and drospirenone and ethinyl estradiol

Timeframe: Arm A: Pre-Cycle Day 1/Cycle 1 Day 14 (Predose, 0.25-12 hours); Cycle 1 Days 1/15 (24 hours). Arm B: Pre-Cycle Day 1/Cycle 1 Day 10 (Predose, 0.5-10 hours); Days 2/11 (24 h), 3/12 (48 h), 4/13 (72 h), 5/14 (96 h); Cycle 1 Days 1/15 (120 h). 21-day cycle.

Time to Maximum Concentration (Tmax) of repaglinide, midazolam, and drospirenone and ethinyl estradiol

Area Under the Curve to Last Measurable Concentration (AUClast) of repaglinide, midazolam, and drospirenone and ethinyl estradiol

Area Under the Curve to Infinity (AUCinf) of repaglinide, midazolam, and drospirenone and ethinyl estradiol

Trial details

NCT IDNCT07340190

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-03-09

Contact for this trial

Novartis Pharmaceuticals

1-888-669-6682 novartis.email@novartis.com

View on ClinicalTrials.gov More Advanced Malignancies trials