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

First listed
May 17, 2019
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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