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
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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.

Condition or disease Intervention/treatment Phase
Pain Drug: AZD1386 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : January 2009
Actual Study Completion Date : February 2009

Arm Intervention/treatment
Experimental: 1 Drug: AZD1386
1 dose of oral solution

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. AZD1386 metabolites in plasma+excreta if feasable [ Time Frame: Predose, 1h, 4h, 8h 24h ]
  2. Safety + tolerability of AZD1386 [ Time Frame: Predose, 2h, 6h, 12h, 24h, 48h, 168h ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00832169

United Kingdom
Research Site
Macclesfield, Cheshire, United Kingdom
Sponsors and Collaborators
Principal Investigator: Raj Chetty, MD AstraZeneca R&D, CPU Alderley Park, UK
Study Chair: Lars Ståhle, MD AstraZeneca R&D, Södertälje, Sweden

Responsible Party: Rolf Karlsten, MD, PhD, Medical Science Director, Emerging Analgesia, Neuroscience, AstraZeneca R&D Södertälje, Sweden Identifier: NCT00832169     History of Changes
Other Study ID Numbers: D5090C00015
EudractCT: 2008-006552-22
First Posted: January 30, 2009    Key Record Dates
Last Update Posted: April 28, 2009
Last Verified: April 2009

Keywords provided by AstraZeneca: