A Phase 1, Open-label, Drug-drug-interaction Study to Determine the Effect of Rucaparib on the Pharmacokinetics of Oral Rosuvastatin (Arm A) and Oral Contraceptives (Ethinylestradiol and Levonorgestrel) (Arm B) in Patients With Advanced Solid Tumors
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- pharmaand GmbH
- Enrollment
- 36
- Locations
- 7
- Primary Endpoint
- PK parameters for oral rosuvastatin, ethinylestradiol and levonorgestrel without and with rucaparib treatment.
Study Overview
Brief Summary
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.
Detailed Description
This is a Phase 1, open-label, drug-drug-interaction (DDI) study in patients with advanced solid tumor. In Part I, the effects of rucaparib (600 mg twice daily [BID]) on the PK of oral rosuvastatin (Arm A) and the combined oral contraceptives (ethinylestradiol and levonorgestrel; Arm B) will be assessed.
Part I: patients will receive single oral doses of rosuvastatin or oral contraceptives (according to assigned arm) on Day 1 and Day 19. Continuous treatment with rucaparib at 600 mg BID will commence on Day 5 and continue until the end of Part I (Day 23).
Part II (optional): treatment with rucaparib in 28-day cycles may continue (at the discretion of the Investigator) until progression of disease, unacceptable toxicity, or other reason for discontinuation.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Arm A - rucaparib and oral rosuvastatin
Intervention: Rucaparib (Drug)
Arm A - rucaparib and oral rosuvastatin
Intervention: Rosuvastatin (Drug)
Arm B - rucaparib and oral contraceptives
Intervention: Rucaparib (Drug)
Arm B - rucaparib and oral contraceptives
Intervention: Oral Contraceptives (Drug)
Outcomes
Primary Outcomes
PK parameters for oral rosuvastatin, ethinylestradiol and levonorgestrel without and with rucaparib treatment.
Time Frame: Day 1 to Day 23
AUC up to time infinity, with extrapolation of the terminal phase (AUC0-inf)
Secondary Outcomes
- Incidence of clinical laboratory abnormalities [Safety and Tolerability](From Day 1 to last patient visit in Part II (approximately 2 years))
- Incidence of dose modifications [Safety and Tolerability](From Day 1 to last patient visit in Part II (approximately 2 years))
- PK parameters for oral rosuvastatin, ethinylestradiol and levonorgestrel without and with rucaparib treatment.(Day 1 to Day 23)
- The following secondary PK parameter will be calculated for rucaparib.(Day 1 to Day 23)
- Incidence of Adverse Events [Safety and Tolerability](From Day 1 to last patient visit in Part II (approximately 2 years))