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Excretion of Radiolabelled AZD0837

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00812643
First received: December 19, 2008
Last updated: March 10, 2009
Last verified: March 2009
  Purpose

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 Intervention Phase
Healthy
Drug: AZD0837
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PK variables of AZD0837, AR-H069927XX, and AR-H067637XX. [ Time Frame: Frequent sampling during 24 hours. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 8
Study Start Date: January 2009
Study Completion Date: February 2009
Intervention Details:
    Drug: AZD0837
    Oral solution, dosing through the Loc-I-Gut catheter, single dose
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00812643

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

No publications provided

Responsible Party: Karin Wåhlander, MSD, AstraZeneca R&D Mölndal
ClinicalTrials.gov Identifier: NCT00812643     History of Changes
Other Study ID Numbers: D1250C00032
Study First Received: December 19, 2008
Last Updated: March 10, 2009
Health Authority: Sweden: Medical Products Agency

Keywords provided by AstraZeneca:
pharmacokinetics

ClinicalTrials.gov processed this record on November 19, 2014