Excretion of Radiolabelled AZD0837

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: NCT00812643
Recruitment Status : Completed
First Posted : December 22, 2008
Last Update Posted : March 11, 2009
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Brief Summary:
This is an explorative study and the scientific question to be investigated in this study is if AZD0837 and/or its metabolites AR-H069927XX and AR-H067637XX and other unknown metabolites are excreted into the bile.

Condition or disease Intervention/treatment Phase
Healthy Drug: AZD0837 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: An Open, Single Centre Pharmacokinetic (Phase 1) Study of the Biliary Excretion of AZD0837 and Metabolites Following a Single Dose of [3H] AZD0837 Given in the Duodenum Via a Loc-I-Gut Catheter to Young Healthy Male Subjects
Study Start Date : January 2009
Actual Study Completion Date : February 2009

Intervention Details:
    Drug: AZD0837
    Oral solution, dosing through the Loc-I-Gut catheter, single dose

Primary Outcome Measures :
  1. The amounts of total radioactivity excreted in bile. Metabolic profile of AZD0837 excreted in bile and identification of previously unknown metabolites and the amounts of AZD0837, AR-H069927XX and AR-H067637XX in bile. [ Time Frame: Frequent sampling through a Loc-I-Gut catheter for up to 3 hours post dose. ]

Secondary Outcome Measures :
  1. PK variables of AZD0837, AR-H069927XX, and AR-H067637XX. [ Time Frame: Frequent sampling during 24 hours. ]
  2. Adverse events, physical examination, safety laboratory variables, blood pressure, pulse and electrocardiography. [ Time Frame: Some of the safety variables will be followed at each visit, some less frequent. ]

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • body mass index (BMI) between 19 to 30 kg/m2 and body weight between 50 to 100 kg inclusive

Exclusion Criteria:

  • Significant illness, trauma or surgical procedures.
  • Clinically significant laboratory abnormalities.
  • Clinically significant medical history.

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): NCT00812643

Research Site
Uppsala, Sweden
Sponsors and Collaborators
Principal Investigator: Lars Knutson, MD, PhD Inst för Kirurgiska VetenskaperUppsala Universitet

Responsible Party: Karin Wåhlander, MSD, AstraZeneca R&D Mölndal Identifier: NCT00812643     History of Changes
Other Study ID Numbers: D1250C00032
First Posted: December 22, 2008    Key Record Dates
Last Update Posted: March 11, 2009
Last Verified: March 2009

Keywords provided by AstraZeneca: