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

AstraZeneca

Status and phase

Terminated

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Placebo

Drug: AZD1704

Study type

Interventional

Funder types

Industry

Identifiers

NCT00736788

2008-002153-20

D0980C00005

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy Japanese males and non-fertile females, defined as first generation Japanese (both parents and grandparents are of Japanese origin, the subject is born in Japan and has not been living outside of Japan for more than 5 years) aged 20-45 years .
Clinical normal physical findings
BMI 19 - 27, weight 50 - 95 kg

Exclusion criteria

History of somatic disease/condition or ongoing psychiatric disease/condition that may interfere with the objectives of the study.
History of psychotic disorder among first-degree relatives.
History of use of antipsychotic, antidepressant or anxiolytic drugs, prescribed as well as non-prescribed use.
Smoking more than 7 cigarettes per week or consumption of more than 3 portion of snuff or equivalent per day within 30 days before administration of study drug.