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

Pain Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00692042
• Other study ID #: D0980C00001
• Status: Completed
• Phase: Phase 1
• First received: June 5, 2008
• Last updated: June 23, 2008
• Start date: March 2008
• Est. completion date: June 2008

Study information

• Verified date: June 2008
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• AZD1704
One dose, by mouth

Locations

Country	Name	City	State
United Kingdom	Reserach Site	Macclesfield	Cheshire

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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)	Yes