drugset / Trial / NCT00766012

Study to Assess the Safety, Tolerability and Pharmacokinetics After Multiple Doses of AZD2066 in Japanese Subjects

NCT00766012

Phase 1 Completed 132 enrolled AstraZeneca
RandomizedParallel-groupQuadruple-blindBasic science

Summary

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of AZD2066 when given as multiple doses to Japanese healthy male subjects. Four (4) consecutive multiple-ascending panels are planned. Subjects will start with an initial single dose that is followed by a wash-out period of 48 hours to adequately define the single-dose pharmacokinetics. For the third and forth dose panels, the wash-out period will be extended to be 96 hours to evaluate the safety of subjects. Thereafter the subjects will be dosed once daily for 10 days. Ten (10) subjects will be allocated to each dose panel and randomized to receive either AZD2066 or placebo.

Timeline

Start
2008-09
Primary completion
Completion
2009-07

Drugs

EvaluationDrugModalityDoseRoute
Subject AZD2066 Small molecule Oral

Indications

No indication recorded.