Effect of Ketoconazole on Biliary Excretion of AZD0837

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AZD0837; Drug: ketoconazole

• Registration Number: NCT00812344
• Lead Sponsor: AstraZeneca

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-19
• Study First Submitted QC: 2008-12-19
• Study First Posted: 2008-12-22
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-02
• Last Update Posted: 2010-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	AZD0837	-
2	AZD0837	AZD0837 + Ketoconazole
2	ketoconazole	AZD0837 + Ketoconazole

Primary Outcome Measures

Name	Time	Method
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 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.
Pharmacogenetics	One sampling during the study.

Trial Locations

Locations (1)

Research Site; 🇸🇪 Uppsala, Sweden