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

AstraZeneca1 site in 1 country80 target enrollmentMarch 2008

ConditionsPain

InterventionsAZD1704

Overview

Phase: Phase 1
Intervention: AZD1704
Conditions: Pain
Sponsor: AstraZeneca
Enrollment: 80
Locations: 1
Primary Endpoint: To investigate the safety and tolerability of AZD1704 following single ascending doses in healthy volunteers.
Status: Completed
Last Updated: 17 years ago

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

Registry

clinicaltrials.gov

Start Date

March 2008

End Date

June 2008

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

•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.

Intervention: AZD1704

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

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))