NCT00692042

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for phase_1 pain

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 6, 2008

Completed
Last Updated

June 24, 2008

Status Verified

June 1, 2008

Enrollment Period

3 months

First QC Date

June 5, 2008

Last Update Submit

June 23, 2008

Conditions

Pain

Keywords

Safetytolerability

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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)

Study Arms (1)

1

EXPERIMENTAL
Drug: AZD1704

Interventions

AZD1704DRUG

One dose, by mouth

1

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers, man or woman of non child-bearing potential
  • Provision of signed informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reserach Site

Macclesfield, Cheshire, United Kingdom

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Billy Fahy, MD

    AstraZeneca R&D CPU Nottingham, UK

    PRINCIPAL INVESTIGATOR

  • Lars Ståhle, MD

    AstraZeneca R&D Södertälje, Sweden

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 5, 2008

First Posted

June 6, 2008

Study Start

March 1, 2008

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

June 24, 2008

Record last verified: 2008-06

Locations

GB(1)