Investigation of Rate+Extent of Excretion of Radioactivity in Urine+Faeces After Oral Administration of [14C]AZD1386

NCT ID: NCT00832169

Last Updated: 2009-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

AZD1386

Intervention Type DRUG

1 dose of oral solution

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AZD1386

1 dose of oral solution

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

AstraZeneca R&D Södertälje, Sweden

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Raj Chetty, MD

Role: PRINCIPAL_INVESTIGATOR

AstraZeneca R&D, CPU Alderley Park, UK

Lars Ståhle, MD

Role: STUDY_CHAIR

AstraZeneca R&D, Södertälje, Sweden

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Macclesfield, CHESHIRE, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EudractCT: 2008-006552-22

Identifier Type: -

Identifier Source: secondary_id

D5090C00015

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.