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OpenTrials
Completed

NCT Number: NCT00812643

Excretion of Radiolabelled AZD0837

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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Uppsala, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AZD0837

Drug

Oral solution, dosing through the Loc-I-Gut catheter, single dose

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2009
Study completion
2009
First posted
Dec 22, 2008
Registry last updated
Mar 11, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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