An Abiraterone Acetate Plus Prednisone Drug-Drug Interaction Study With Dextromethorphan and Theophylline in Patients With Metastatic Castration-Resistant Prostate Cancer
This is an open-label (identity of assigned study drug will be known) study of abiraterone
acetate plus prednisone in male patients with metastatic castration-resistant prostate
cancer. This study will consist of screening, treatment, and follow-up periods, and will
have 2 study groups. Patients in Group A and B will receive daily abiraterone acetate (1000
mg) plus prednisone (5 mg) twice daily beginning on Cycle 1 Day 1 until disease progression.
Patients in Group A will take dextromethorphan hydrobromide 30 mg administered orally once
daily on Day -8 and Day 8 of Cycle 1. Patients in Group B will take theophylline 100 mg
administered orally once daily on Day -8 and Day 8 of Cycle 1. Serial pharmacokinetic
samples will be collected and safety will be monitored throughout the study.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Ratio of the mean area under the concentration curve (AUC) of dextromethorphan, dextrorphan, and parent/metabolite, with and without co-administration of abiraterone acetate and prednisone
Cycle 1 Day -8 and Day 8
No
Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC
United States: Food and Drug Administration
CR017128
NCT01017939
January 2010
April 2012
Name | Location |
---|---|
Fountain Valley, California 92708 | |
Austin, Texas 78705 | |
Tower Cancer Research Foundation | Beverly Hills, California 90211 |
START - South Texas Accelerated Research Therapeutics, LLC | San Antonio, Texas 78229 |