NCT00832169

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 AZD1386 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
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 30, 2009

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

April 28, 2009

Status Verified

April 1, 2009

First QC Date

January 29, 2009

Last Update Submit

April 27, 2009

Conditions

Pain

Keywords

Pain

Outcome Measures

Primary Outcomes (2)

  • Excretion (rate+extent) of radioactivity in urine+faeces following oral administration of [14C]AZD1386

    Until >90% of predicted total radioactivity has been recovered

  • Pharmacokinetics of total radioactivity in plasma + unchanged AZD1386 in plasma Metabolite profile in plasma+excreta

    Predose, + postdose 0.5h, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h, 96h, 120h, 144hPredose + postdose 1h, 4h, 8h, 24h for excreta from predose (baseline) + postdose from 0h continously until 144h

Secondary Outcomes (2)

  • AZD1386 metabolites in plasma+excreta if feasable

    Predose, 1h, 4h, 8h 24h

  • Safety + tolerability of AZD1386

    Predose, 2h, 6h, 12h, 24h, 48h, 168h

Study Arms (1)

1

EXPERIMENTAL
Drug: AZD1386

Interventions

AZD1386DRUG

1 dose of oral solution

1

Eligibility Criteria

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

You may qualify if:

  • Body Mass Index of 18 - 30 and weight of 50 to 100 kilos.
  • Healthy volunteer must have regular bowel movements (at least once daily)

You may not qualify if:

  • History of psychiatric or somatic disease/condition, which may interfere with the objectives of the study as judged by the investigator.
  • A family history of short QT syndrome or sudden cardiac death amongst first degree relatives.
  • Any clinically important abnormalities in heart rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Macclesfield, CHESHIRE, United Kingdom

Location

MeSH Terms

Conditions

Pain

Interventions

AZD1386

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Raj Chetty, 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 29, 2009

First Posted

January 30, 2009

Study Start

January 1, 2009

Study Completion

February 1, 2009

Last Updated

April 28, 2009

Record last verified: 2009-04

Locations

GB(1)