NCT03954366

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: pharmaand GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neoplasms

Interventions

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

Timeline

• Start date: 2019-04-25
• Primary completion: 2019-12-06
• Completion: 2021-06-09
• First posted: 2019-05-17
• Last updated: 2023-06-08

Locations

7 sites across 3 countries: Hungary, Poland, Slovakia