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

NCT ID: NCT00736788

Last Updated: 2010-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2008-09-30

Brief Summary

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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

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Conditions

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Healthy Volunteers

Keywords

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AZD1704, Japanese Healthy Volunteers, Phase I study, Single Ascending Dose Safety, Tolerability Pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Four different oral dose levels of a suspension containing AZD1704

Group Type EXPERIMENTAL

AZD1704

Intervention Type DRUG

single dose oral suspension, 4 different dose levels

2

oral suspension

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

single dose oral suspension

Interventions

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AZD1704

single dose oral suspension, 4 different dose levels

Intervention Type DRUG

Placebo

single dose oral suspension

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca R&D Södertälje Sweden

Principal Investigators

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Rolf Karlsten

Role: STUDY_DIRECTOR

AstraZeneca R&D Södertälje

Ulrike Lorch

Role: PRINCIPAL_INVESTIGATOR

Richmond Pharmacology Limited

Locations

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Research Site

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2008-002153-20

Identifier Type: -

Identifier Source: secondary_id

D0980C00005

Identifier Type: -

Identifier Source: org_study_id