Study to Investigate Safety, Tolerability and Pharmacokinetics of a Single Ascending Dose of AZD1704

Phase 1

Completed

• Conditions: Pain
• Interventions: Drug: AZD1704

• Registration Number: NCT00692042
• Lead Sponsor: AstraZeneca

Brief Summary

The primary aim for this study is to investigate the safety and tolerability of the AZD1704, first time in man.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Status Verified: 2008-06
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Study First Submitted: 2008-06-05
• Study First Submitted QC: 2008-06-05
• Study First Posted: 2008-06-06
• Last Update Submitted: 2008-06-23
• Last Update Posted: 2008-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Healthy volunteers, man or woman of non child-bearing potential
• Provision of signed informed consent.

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Exclusion Criteria

• History of somatic disease/condition that may interfere with the objectives ot the study, as judged by the Investigator. History of seizures, with the exception of single occasions fever induced seizures in childhood.
• History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder according to the criteria in the DSM of Mental Disorder, 4th edition
• History of use of antipsychotic, antidepressant or anxiolytic drugs for the treatment of psychiatric disease or symptoms, prescribed as well as non-prescribed use.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AZD1704	-

Primary Outcome Measures

Name	Time	Method
To investigate the safety and tolerability of AZD1704 following single ascending doses in healthy volunteers.	At screening, during residential period (daily) and at follow-up

Secondary Outcome Measures

Name	Time	Method
To investigate the subjective CNS effects of specific adjectives (stimulated, anxious, sedated, down and high) rated on visual analogue mood scale (VAMS).	During residential period (daily)

Trial Locations

Locations (1)

Reserach Site; 🇬🇧 Macclesfield, Cheshire, United Kingdom