Excretion of Radiolabelled AZD0837

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00812643

Enrollment

Registered

2008-12-22

Start date

2009-01-31

Completion date

2009-02-28

Last updated

2009-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

pharmacokinetics

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.

Interventions

DRUGAZD0837

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026