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

June 23, 2008 updated by: AstraZeneca

A Phase I, First Time in Man, Single-Centre, Randomised, Double-Blind (Within Panels), Placebo-Controller Study to Investigate Safety, Tolerability and Pharmacokinetics of AZD1704 After Administration of Oral Single Ascending Doses in Healthy Volunteers

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Cheshire
      • Macclesfield, Cheshire, United Kingdom
        • Reserach Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: AZD1704
One dose, by mouth

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Billy Fahy, MD, AstraZeneca R&D CPU Nottingham, UK
  • Study Chair: Lars Ståhle, MD, AstraZeneca R&D Sodertalje, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

June 5, 2008

First Submitted That Met QC Criteria

June 5, 2008

First Posted (Estimate)

June 6, 2008

Study Record Updates

Last Update Posted (Estimate)

June 24, 2008

Last Update Submitted That Met QC Criteria

June 23, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • D0980C00001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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