Assess Safety, Tolerability and Pharmacokinetic (PK) of AZD1704 in Healthy Japanese Male and Non-Fertile Female Volunteers

Summary

The primary objective of this study is to investigate the safety and tolerability of AZD1704 following single ascending doses in healthy Japanese male and non-fertile female volunteers by assessment of adverse events (AEs), vital signs (supine and standing blood pressure, pulse rate, respiratory rate and body temperature), safety laboratory variables and 12 lead electrocardiography (ECG). The secondary objectives of the study are: to investigate the subjective CNS effects of orally administered AZD1704 in healthy Japanese male and non-fertile female volunteers on a psychometric rating scale by assessment of specific adjectives (stimulated, anxious, sedated, down and high) rated on visual analogue mood scale (VAMS) and to investigate the pharmacokinetic profile of AZD1704 following single ascending doses in healthy Japanese male and non-fertile female volunteers.

Timeline

Start

2008-08

Primary completion

2008-09

Completion

2008-09

Outcome

Outcome not reported

Stopped: “AZD1704 has essentially similar PK profile in Japanese subjects as in Caucasians. One of the main purposes of the study has thereby been achieved.”

Drugs

Indications

No indication recorded.