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Completed

NCT Number: NCT00692042

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

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

Completed

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Reserach Site

Macclesfield, Cheshire, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AZD1704

Drug

One dose, by mouth

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 6, 2008
Registry last updated
Jun 24, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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