Effect of Ketoconazole on Biliary Excretion of AZD0837

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00812344
• Other study ID #: D1250C00029
• Status: Completed
• Phase: Phase 1
• First received: December 19, 2008
• Last updated: December 2, 2010
• Start date: December 2008
• Est. completion date: March 2009

Study information

• Verified date: December 2010
• 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 is if the biliary excretion of AZD0837 and its metabolites AR-H069927XX and AR-H067637XX are affected by co-administration with ketoconazole

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2009
• Est. primary completion date: March 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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• AZD0837
Oral solution, dosing through the Loc-I-Gut catheter, single dose
• Ketoconazole
tablets, orally, once daily for 3 days
• ketoconazole
dissolved tablets, 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	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.	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
Secondary	Pharmacogenetics		One sampling during the study.	No