Drug-drug Interaction Study Using Rosuvastatin as a Breast Cancer Resistant Protein (Efflux Transporter), Organic Anion-transporting Polypeptide (OATP)1B1, and OATP1B3 (Uptake Transporters) Probe Substrate

Phase 1 Completed 30 enrolled Bayer

NaSingle-groupOpen-label

Summary

Evaluation of the potential perpetrator effect of BAY1841788 (ODM-201) on rosuvastatin pharmacokinetics. PK of BAY1841788 (ODM-201) after single and repeated administration in male and female subjects.

Timeline

Start: 2016-02
Primary completion: 2016-05
Completion: 2016-08

Publications

Zurth C, Nykanen P, Wilkinson G, Taavitsainen P, Vuorela A, Huang F, Reschke S, Koskinen M. Clinical Pharmacokinetics of the Androgen Receptor Inhibitor Darolutamide in Healthy Subjects and Patients with Hepatic or Renal Impairment. Clin Pharmacokinet. 2022 Apr;61(4):565-575. doi: 10.1007/s40262-021-01078-y. Epub 2021 Dec 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Darolutamide	Other / unclassified	600 mg	Oral
Subject	Rosuvastatin	Small molecule	5 mg	—

Indications

No indication recorded.