Effect of Ketoconazole Inhibition of CYP3A on Urinary Excretion of Docetaxel

Summary

Primary Objective: * To confirm if ketoconazole inhibition of CYP3A activity affects fractional excretion of docetaxel in the urine. Secondary Objective: * To compare the metabolite ratios of the major metabolites of docetaxel in the presence and absence of CYP3A inhibition.

Timeline

Start

2006-10

Primary completion

2013-10

Completion

2013-10

Publications

• Background Goh BC, Lee SC, Wang LZ, Fan L, Guo JY, Lamba J, Schuetz E, Lim R, Lim HL, Ong AB, Lee HS. Explaining interindividual variability of docetaxel pharmacokinetics and pharmacodynamics in Asians through phenotyping and genotyping strategies. J Clin Oncol. 2002 Sep 1;20(17):3683-90. doi: 10.1200/JCO.2002.01.025.
• Background Tham LS, Goh BC, Wang LZ, Yong WP, Wong CI, Lee SC, Soo R, Sukri N, Lee HS. Ketoconazole inhibition of CYP3A activity made midazolam but not docetaxel pharmacokinetics more predictable. (Abstr) 2006 American Society for Clinical Pharmacology and Therapeutics Annual Meeting (Baltimore, MD).

Drugs

Indications