Drug Interaction Study to Asses Multiple Doses of ZD4054 (Zibotentan)

Phase 1 Completed 12 enrolled AstraZeneca

RandomizedCrossoverOpen-labelBasic science

Summary

The purpose of the study is to to assess the effect of multiple oral doses of ZD4054 (Zibotentan) on the pharmacokinetics of a CYP450 3A Probe (midazolam) in healthy male subjects.

Timeline

Start: 2008-07
Primary completion: 2008-08
Completion: 2008-08

Outcome

Met primary endpoint

paper The upper limits of the 90% CIs for the AUC(0-infinity) and C(max) ratios were below the predefined level of 1.5 (1.37 and 1.32, respectively). PMID 20678684 ↗

Publications

Tomkinson HK, Kemp JV, Wollseifen T, Morris T, Oliver SD. An open-label, randomized, single-center, two-period, phase I, crossover study of the effect of zibotentan (ZD4054) on the pharmacokinetics of midazolam in healthy male volunteers. Clin Ther. 2010 Jul;32(7):1372-86. doi: 10.1016/j.clinthera.2010.07.013.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Midazolam	Small molecule	7.5 mg	—
Subject	Zibotentan	Small molecule	10 mg	Oral

Indications

No indication recorded.