Study Evaluating Ascending Single-Dose Of Bosutinib Administered With Multiple Doses Of Ketoconazole To Healthy Subjects

Phase 1 Completed 48 enrolled Wyeth is now a wholly owned subsidiary of Pfizer

RandomizedSingle-groupDouble-blind

Summary

The purpose of this study is to assess the safety and tolerability of ascending single oral doses of bosutinib administered with multiple doses of ketoconazole and to provide the pharmacokinetic profile of bosutinib when administered with multiple doses of ketoconazole and with food in healthy adult subjects.

Timeline

Start: 2008-04
Primary completion: 2008-08
Completion: 2008-08

Publications

Abbas R, Leister C, El Gaaloul M, Chalon S, Sonnichsen D. Ascending single-dose study of the safety profile, tolerability, and pharmacokinetics of bosutinib coadministered with ketoconazole to healthy adult subjects. Clin Ther. 2012 Sep;34(9):2011-9.e1. doi: 10.1016/j.clinthera.2012.07.006. Epub 2012 Aug 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bosutinib	Small molecule	100 mg	Oral
Subject	Bosutinib	Small molecule	200 mg	Oral
Subject	Bosutinib	Small molecule	300 mg	Oral
Subject	Bosutinib	Small molecule	400 mg	Oral
Subject	Bosutinib	Small molecule	500 mg	Oral
Subject	Bosutinib	Small molecule	600 mg	Oral

Study Evaluating Ascending Single-Dose Of Bosutinib Administered With Multiple Doses Of Ketoconazole To Healthy Subjects

Summary

Timeline

Publications

Drugs

Indications