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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00692042
First received: June 5, 2008
Last updated: June 23, 2008
Last verified: June 2008
  Purpose

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


Condition Intervention Phase
Pain
Drug: AZD1704
Phase 1

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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: March 2008
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD1704
One dose, by mouth

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00692042

Locations
United Kingdom
Reserach Site
Macclesfield, Cheshire, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Billy Fahy, MD AstraZeneca R&D CPU Nottingham, UK
Study Chair: Lars Ståhle, MD AstraZeneca R&D Södertälje, Sweden
  More Information

No publications provided

Responsible Party: Rolf Karlsten, MD, PhD, Medical Science Director, Emerging Analgesia, Neuroscience, AstraZeneca R&D Södertälje, Sweden
ClinicalTrials.gov Identifier: NCT00692042     History of Changes
Other Study ID Numbers: D0980C00001
Study First Received: June 5, 2008
Last Updated: June 23, 2008
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
Safety
tolerability

ClinicalTrials.gov processed this record on April 17, 2014