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
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, see Learn About Clinical Studies.

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 September 16, 2014