Pharmacokinetic Drug-Drug Interaction Study of Rucaparib

Phase 1 Completed 17 enrolled pharmaand GmbH

NaSingle-groupOpen-labelOther

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.

Timeline

Start: 2016-04
Primary completion: 2017-03
Completion: 2019-09

Publications

Xiao JJ, Nowak D, Ramlau R, Tomaszewska-Kiecana M, Wysocki PJ, Isaacson J, Beltman J, Nash E, Kaczanowski R, Arold G, Watkins S. Evaluation of Drug-Drug Interactions of Rucaparib and CYP1A2, CYP2C9, CYP2C19, CYP3A, and P-gp Substrates in Patients With an Advanced Solid Tumor. Clin Transl Sci. 2019 Jan;12(1):58-65. doi: 10.1111/cts.12600. Epub 2018 Dec 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Caffeine	Small molecule	200 mg	—
Subject	Digoxin	Other / unclassified	0.25 mg	—
Subject	Midazolam	Small molecule	2 mg	—
Subject	Omeprazole	Other / unclassified	40 mg	—
Subject	Rucaparib	Small molecule	600 mg	Oral
Subject	Warfarin	Small molecule	10 mg	—
Background	Vitamin K	Unknown	10 mg	—

Pharmacokinetic Drug-Drug Interaction Study of Rucaparib

Summary

Timeline

Publications

Drugs

Indications