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
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 April 17, 2014