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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00832169
Recruitment Status : Completed
First Posted : January 30, 2009
Last Update Posted : April 28, 2009
Information provided by:

January 29, 2009
January 30, 2009
April 28, 2009
January 2009
Not Provided
  • 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 ]
  • 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 ]
Same as current
Complete list of historical versions of study NCT00832169 on Archive Site
  • AZD1386 metabolites in plasma+excreta if feasable [ Time Frame: Predose, 1h, 4h, 8h 24h ]
  • Safety + tolerability of AZD1386 [ Time Frame: Predose, 2h, 6h, 12h, 24h, 48h, 168h ]
Same as current
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Investigation of Rate+Extent of Excretion of Radioactivity in Urine+Faeces After Oral Administration of [14C]AZD1386
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.
Not Provided
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Drug: AZD1386
1 dose of oral solution
Experimental: 1
Intervention: Drug: AZD1386
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
February 2009
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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.
Sexes Eligible for Study: Male
35 Years to 50 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
EudractCT: 2008-006552-22
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Rolf Karlsten, MD, PhD, Medical Science Director, Emerging Analgesia, Neuroscience, AstraZeneca R&D Södertälje, Sweden
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Principal Investigator: Raj Chetty, MD AstraZeneca R&D, CPU Alderley Park, UK
Study Chair: Lars Ståhle, MD AstraZeneca R&D, Södertälje, Sweden
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP