Drug-Drug Interaction Study of Rucaparib, Rosuvastatin and Oral Contraceptives

Sponsor
pharmaand GmbH
Study ID
NCT03954366
Phase
PHASE1
Status
Completed

Conditions

  • Neoplasms

Eligibility Criteria

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

Interventions

  • Rucaparib — DRUG
    Rucaparib 600 mg BID commencing on Day 5 until Day 23.
  • Rosuvastatin — DRUG
    Single dose of 20mg oral rosuvastatin on Day 1 and Day 19 only.
  • Oral Contraceptives — DRUG
    Single dose of combined oral contraceptive (30 μg ethinylestradiol and 150 μg levonorgestrel) on Day 1 and Day 19 only.

Study Details

This study will investigate the drug-drug interactions (DDIs) between rucaparib and oral rosuvastatin (Arm A), and between rucaparib and oral ethinylestradiol and levonorgestrel (Arm B), with rucaparib as a perpetrator.

Key Dates

Start date
Apr 25, 2019
Status verified
Jun 2023
Primary completion
Dec 6, 2019
Completion
Jun 9, 2021

Study Design

Enrollment
36 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Other: Arm A - rucaparib and oral rosuvastatin
  • Other: Arm B - rucaparib and oral contraceptives

Primary Outcome Measure

PK parameters for oral rosuvastatin, ethinylestradiol and levonorgestrel without and with rucaparib treatment. [ Time Frame: Day 1 to Day 23 ]

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