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

Phase 1 Completed 36 enrolled pharmaand GmbH

Non-randomizedParallel-groupOpen-labelOther

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.

Timeline

Start: 2019-04-25
Primary completion: 2019-12-06
Completion: 2021-06-09

Publications

Liao M, Jeziorski KG, Tomaszewska-Kiecana M, Lang I, Jasiowka M, Skarbova V, Centkowski P, Ramlau R, Gornas M, Lee J, Edwards S, Habeck J, Nash E, Grechko N, Xiao JJ. A phase 1, open-label, drug-drug interaction study of rucaparib with rosuvastatin and oral contraceptives in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2021 Nov;88(5):887-897. doi: 10.1007/s00280-021-04338-7. Epub 2021 Aug 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Levonorgestrel	Small molecule	150 ug	Oral
Subject	Rosuvastatin	Small molecule	20 mg	Oral
Subject	Rucaparib	Small molecule	600 mg	—
Subject	ethinyl estradiol	Small molecule	30 ug	Oral

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

Summary

Timeline

Publications

Drugs

Indications