Excretion of Radiolabelled AZD0837

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00812643
• Other study ID #: D1250C00032
• Status: Completed
• Phase: Phase 1
• First received: December 19, 2008
• Last updated: March 10, 2009
• Start date: January 2009
• Est. completion date: February 2009

Study information

• Verified date: March 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Sweden	Research Site	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	PK variables of AZD0837, AR-H069927XX, and AR-H067637XX.		Frequent sampling during 24 hours.	No
Secondary	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.	Yes