- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00832169
Investigation of Rate+Extent of Excretion of Radioactivity in Urine+Faeces After Oral Administration of [14C]AZD1386
April 27, 2009 updated by: AstraZeneca
An Open, Single Dose, Phase I Study of the Excretion of Radioactivity, Metabolism and Pharmacokinetics Following Oral Administration of [14C]AZD1386 to Healthy Male Volunteers
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
6
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Cheshire
-
Macclesfield, Cheshire, United Kingdom
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
1 dose of oral solution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Excretion (rate+extent) of radioactivity in urine+faeces following oral administration of [14C]AZD1386
Time Frame: Until >90% of predicted total radioactivity has been recovered
|
Until >90% of predicted total radioactivity has been recovered
|
Pharmacokinetics of total radioactivity in plasma + unchanged AZD1386 in plasma Metabolite profile in plasma+excreta
Time Frame: 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
|
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 Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AZD1386 metabolites in plasma+excreta if feasable
Time Frame: Predose, 1h, 4h, 8h 24h
|
Predose, 1h, 4h, 8h 24h
|
Safety + tolerability of AZD1386
Time Frame: Predose, 2h, 6h, 12h, 24h, 48h, 168h
|
Predose, 2h, 6h, 12h, 24h, 48h, 168h
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Raj Chetty, MD, AstraZeneca R&D, CPU Alderley Park, UK
- Study Chair: Lars Ståhle, MD, AstraZeneca R&D, Södertälje, Sweden
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Study Completion (Actual)
February 1, 2009
Study Registration Dates
First Submitted
January 29, 2009
First Submitted That Met QC Criteria
January 29, 2009
First Posted (Estimate)
January 30, 2009
Study Record Updates
Last Update Posted (Estimate)
April 28, 2009
Last Update Submitted That Met QC Criteria
April 27, 2009
Last Verified
April 1, 2009
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- D5090C00015
- EudractCT: 2008-006552-22
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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