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

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07340190
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Malignancies

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • pelabresib — DRUG
    pelabresib 225 mg orally (PO) once daily (QD) for 14 days, followed by a 7-day break
  • repaglinide — DRUG
    0.5 mg repaglinide tablet administered orally on Pre-Cycle Day 1 and Cycle 1 Day 14
  • midazolam — DRUG
    2 mg/mL midazolam oral solution administered orally on Pre-Cycle Day 1 and Cycle 1 Day 14
  • drospirenone — DRUG
    3 mg drospirenone tablet administered orally on Pre-Cycle Day 1 and Cycle 1 Day 10
  • ethinyl estradiol — DRUG
    0.03 mg ethinyl estradiol tablet administered orally on Pre-Cycle Day 1 and Cycle 1 Day 10

Study Details

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.

Key Dates

First listed
Jan 14, 2026
Start date
Jun 12, 2026
Status verified
Jul 2026
Primary completion
Mar 9, 2028
Completion
Apr 7, 2028

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Part 1 (PK profiles of victim drugs): • Arm A: repaglinide + midazolam + pelabresib Part 2 (Continued treatment): After completing Part 1, in case of clinical benefit, participants can continue with pelabresib treatment in Part 2 until the end of study (EOS) is reached or until the participant meets discontinuation criteria, or until they receive pelabresib treatment via alternative means of access, whichever occurs first.
  • Experimental: Arm B
    Part 1 (PK profiles of victim drugs): • Arm B: drospirenone + ethinyl estradiol + pelabresib Part 2 (Continued treatment): After completing Part 1, in case of clinical benefit, participants can continue with pelabresib treatment in Part 2 until the end of study (EOS) is reached or until the participant meets discontinuation criteria, or until they receive pelabresib treatment via alternative means of access, whichever occurs first.

Primary Outcome Measure

Maximum Plasma Concentration (Cmax) of repaglinide, midazolam, and drospirenone and ethinyl estradiol [ Time Frame: 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. ]

Central Contacts

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