NCT00829088

Brief Summary

The aim of this study is to get information about absorption, distribution, metabolism and excretion as well as the tolerability and safety of AZD2066 in healthy male volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_1 pain

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_1 pain

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

January 1, 2009

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 26, 2009

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

February 25, 2009

Status Verified

February 1, 2009

First QC Date

January 23, 2009

Last Update Submit

February 24, 2009

Conditions

Pain

Keywords

Mass balanceAZD2066PainPain conditions

Outcome Measures

Primary Outcomes (3)

  • Excretion (rate and extent) of radioactivity in urine and faeces following oral administration of [14C]AZD2066

    Until >90% of predicted total radioactivity has been recovered

  • Pharmacokinetics of total radioactivity in plasma and unchanged AZD2066 in plasma

    Sampling at defined timepoints during residential period from pre-dose until 168h post-dose.

  • Metabolite profile in plasma and excreta

    Sampling at defined timepoints during residential period from pre-dose until 48h post-dose.

Secondary Outcomes (2)

  • AZD2066 metabolites in plasma+excreta if feasable

    Sampling at defined timepoints during residential period from pre-dose until 48h post-dose.

  • Safety and tolerability of AZD2066 by assessment of vital signs, laboratory variables, ECG and adverse events

    Assessments taken at visit 1 (enrolment), defined time points pre dose and post dose during visit 2 (residential period) and follow up visit 3.

Interventions

AZD2066DRUG

1 dose oral solution

Eligibility Criteria

Age35 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Provision of signed informed consent
  • Clinically normal physical findings and laboratory values as judged by the investigator and a normal resting ECG.

You may not qualify if:

  • History of somatic disease/condition, which may interfere with the objectives of the study.
  • History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder.
  • Healthy volunteers who have been exposed to radiation levels above background (eg, through X-ray examinations).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Cheshire, United Kingdom

Location

MeSH Terms

Conditions

Pain

Interventions

AZD2066

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Emeline Ramos, MD

    AstraZeneca R&D, CPU Alderley Park, UK

    PRINCIPAL INVESTIGATOR

  • Lars Ståhle, MD

    AstraZeneca R&D, Södertälje, Sweden

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 23, 2009

First Posted

January 26, 2009

Study Start

January 1, 2009

Study Completion

February 1, 2009

Last Updated

February 25, 2009

Record last verified: 2009-02

Locations

GB(1)