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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00692042
First Posted: June 6, 2008
Last Update Posted: June 24, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

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) ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: June 5, 2008
First Posted: June 6, 2008
Last Update Posted: June 24, 2008
Last Verified: June 2008

Keywords provided by AstraZeneca:
Safety
tolerability