NCT02740712

Pharmacokinetic Drug-Drug Interaction Study of Rucaparib

A Phase 1, Open-label, Multiple-probe Drug-drug Interaction Study to Determine the Effect of Rucaparib on Pharmacokinetics of Caffeine, S-Warfarin, Omeprazole, Midazolam, and Digoxin in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: pharmaand GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess pharmacokinetic concentrations of multiple probes alone followed by assessment of the same drug pharmacokinetic concentrations when the patient has steady-state exposure to rucaparib followed by cycle-by-cycle treatment with rucaparib continuing until disease progression or other reason for discontinuation.

Detailed description

This is a Phase 1, open-label, sequential, drug-drug-interaction (DDI) study in patients with advanced solid tumors. The study will consist of 2 parts: a DDI part (Part I) and a rucaparib treatment part (Part II). In Part I, the PK of cytochrome P450 (CYP) cocktail probes: caffeine, S-warfarin, omeprazole, and midazolam and a P-glycoprotein probe (digoxin) will be assessed with and without rucaparib treatment. Patients will receive single doses of CYP drug cocktail (caffeine, warfarin, omeprazole, and midazolam) on Day 1 and Day 12, and single doses of digoxin on Day 2 and Day 13. Continuous treatment with 600 mg rucaparib twice daily (BID) will start on Day 5 and will last until at least Day 16 of Part I. In Part II, the treatment with rucaparib in 28-day cycles will continue until progression of disease, unacceptable toxicity, or other reason for discontinuation.

Conditions

• Neoplasms

Interventions

Type	Name	Description
DRUG	Caffeine	200 mg (4 x 50mg) Tablet
DRUG	Warfarin	10 mg (2 x 5mg) Tablet
DRUG	Omeprazole	40 mg Tablet
DRUG	Midazolam	5 mg/mL
DRUG	digoxin	.25 mg Tablet
DRUG	Vitamin K	10 mg Tablet
DRUG	Rucaparib	200 \& 300 mg tablet

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-03-01
• Completion: 2019-09-01
• First posted: 2016-04-15
• Last updated: 2023-06-09

Locations

3 sites across 1 country: Poland