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

Phase 1

Terminated

• Conditions: Healthy Volunteers
• Interventions: Drug: AZD1704; Drug: Placebo

• Registration Number: NCT00736788
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-14
• Study First Submitted QC: 2008-08-15
• Study First Posted: 2008-08-18
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-08
• Last Update Posted: 2010-12-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AZD1704	Four different oral dose levels of a suspension containing AZD1704
2	Placebo	oral suspension

Primary Outcome Measures

Name	Time	Method
Safety/Tolerability - 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)	From dosing to follow up

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamic VAMS scores of different adjectives (stimulated, anxious, sedated, down and high).	During residential period
Pharmacokinetic profile of AZD1704 following single ascending doses in healthy Japanese male and non-fertile female volunteers	During residential period

Trial Locations

Locations (1)

Research Site; 🇬🇧 London, United Kingdom