Effect of Ketoconazole on Biliary Excretion of AZD0837

An Open, Randomised, Cross-over, Single Centre Pharmacokinetic (Phase I) Study of the Biliary Excretion Following Single Doses of AZD0837, Given in the Duodenum Via a Loc-I-Gut Catheter, Alone or in Combination With Ketoconazole (Once Daily for 4 Days), to Young Healthy Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00812344

Enrollment

Registered

2008-12-22

Start date

2008-12-31

Completion date

2009-03-31

Last updated

2010-12-03

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 is if the biliary excretion of AZD0837 and its metabolites AR-H069927XX and AR-H067637XX are affected by co-administration with ketoconazole

Interventions

DRUGAZD0837

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

DRUGKetoconazole

tablets, orally, once daily for 3 days

DRUGketoconazole

dissolved tablets, dosing through the Loc-I-Gut catheter, single dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

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
Amount of AZD0837, AR-H069927XX, and AR-H067637XX in bile and biliary clearance of AZD0837, AR-H069927XX, and AR-H067637XX.	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.
Pharmacogenetics	One sampling during the study.

Countries

Sweden

Outcome results

None listed

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