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

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: Rucaparib; Drug: Oral Contraceptives; Drug: Rosuvastatin

• Registration Number: NCT03954366
• Lead Sponsor: pharmaand GmbH

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 Timeline

• Study First Submitted: 2019-04-02
• Study Start: 2019-04-25
• Study First Submitted QC: 2019-05-15
• Study First Posted: 2019-05-17
• Primary Completion: 2019-12-06
• Study Completion: 2021-06-09
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-07
• Last Update Posted: 2023-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B - rucaparib and oral contraceptives	Oral Contraceptives	-
Arm A - rucaparib and oral rosuvastatin	Rucaparib	-
Arm A - rucaparib and oral rosuvastatin	Rosuvastatin	-
Arm B - rucaparib and oral contraceptives	Rucaparib	-

Primary Outcome Measures

Name	Time	Method
PK parameters for oral rosuvastatin, ethinylestradiol and levonorgestrel without and with rucaparib treatment.	Day 1 to Day 23	AUC up to time infinity, with extrapolation of the terminal phase (AUC0-inf)

Secondary Outcome Measures

Name	Time	Method
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	Apparent volume of distribution during terminal phase (Vz/F)
The following secondary PK parameter will be calculated for rucaparib.	Day 1 to Day 23	Trough plasma concentration (Cmin)
Incidence of Adverse Events [Safety and Tolerability]	From Day 1 to last patient visit in Part II (approximately 2 years)

Trial Locations

Locations (7)

Zdrowie Kobiety Centrum Leczniczo-Rehabilitacyjne i Medycyny Pracy ATTIS Sp. z o.o., Zakład Onkologii Kobiecej; 🇵🇱 Warszawa, Poland

Summit Clinical Research s.r.o.; 🇸🇰 Bratislava, Slovakia

PRA Magyarország Fázis I-es Klinikai Farmakológiai Vizsgálóhely FMC Dialízis Központ, II. em.; 🇭🇺 Budapest, Hungary

Wojewódzki Szpital Specjalistyczny w Białej Podlaskiej; 🇵🇱 Biała Podlaska, Poland

Ujastek Sp. z o.o. Centrum medyczne; 🇵🇱 Kraków, Poland

Med Polonia Sp. z o.o.; 🇵🇱 Poznań, Poland

BioVirtus Centrum Medyczne; 🇵🇱 Józefów, Poland