Effect of Ketoconazole on Biliary Excretion of AZD0837 - Tabular View

Tracking Information

First Received Date ^ICMJE

December 19, 2008

Last Updated Date

April 1, 2009

Start Date ^ICMJE

December 2008

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Amount of AZD0837, AR-H069927XX, and AR-H067637XX in bile and biliary clearance of AZD0837, AR-H069927XX, and AR-H067637XX. [ Time Frame: Frequent sampling through a Loc-I-Gut catheter for up to 3 hours post dose. ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00812344 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

PK variables of AZD0837, AR-H069927XX, and AR-H067637XX. [ Time Frame: Frequent sampling during 24 hours. ] [ Designated as safety issue: No ]
Adverse events, physical examination, safety laboratory variables, blood pressure, pulse and electrocardiography. [ Time Frame: Some of the safety variables will be followed at each visit, some less frequent. ] [ Designated as safety issue: Yes ]
Pharmacogenetics [ Time Frame: One sampling during the study. ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Effect of Ketoconazole on Biliary Excretion of AZD0837

Official Title ^ICMJE

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

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

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: AZD0837
Oral solution, dosing through the Loc-I-Gut catheter, single dose
Drug: Ketoconazole
tablets, orally, once daily for 3 days
Drug: ketoconazole
dissolved tablets, dosing through the Loc-I-Gut catheter, single dose

Study Arms / Comparison Groups

1: Experimental
Intervention: Drug: AZD0837
2: Active Comparator
AZD0837 + Ketoconazole
Interventions:
- Drug: AZD0837
- Drug: Ketoconazole
- Drug: ketoconazole

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

April 2009

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Sweden

Administrative Information

NCT ID ^ICMJE

NCT00812344

Responsible Party

Karin Wåhlander, MSD, AstraZeneca R&D Mölndal

Study ID Numbers ^ICMJE

D1250C00029

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Lars Knutson, MD, PhD

Inst för Kirurgiska VetenskaperUppsala Universitet

Information Provided By

AstraZeneca

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP