Excretion of Radiolabelled AZD0837

Phase 1

Completed

• Conditions: Healthy

• Registration Number: NCT00812643
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-12-19
• Study First Submitted QC: 2008-12-19
• Study First Posted: 2008-12-22
• Study Start: 2009-01
• Study Completion: 2009-02
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-10
• Last Update Posted: 2009-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.	Frequent sampling through a Loc-I-Gut catheter for up to 3 hours post dose.

Secondary Outcome Measures

Name	Time	Method
PK variables of AZD0837, AR-H069927XX, and AR-H067637XX.	Frequent sampling during 24 hours.
Adverse events, physical examination, safety laboratory variables, blood pressure, pulse and electrocardiography.	Some of the safety variables will be followed at each visit, some less frequent.

Trial Locations

Locations (1)

Research Site; 🇸🇪 Uppsala, Sweden