Effect of Ketoconazole on Biliary Excretion of AZD0837 - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00812344

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: AZD0837 Drug: Ketoconazole Drug: ketoconazole	Phase I

Study Type:	Interventional
Study Design:	Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
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

Resource links provided by NLM:

Drug Information available for: Ketoconazole Fungarest

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	20
Study Start Date:	December 2008
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: AZD0837 Oral solution, dosing through the Loc-I-Gut catheter, single dose
2: Active Comparator AZD0837 + Ketoconazole	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

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00812344

Locations

Sweden
Research Site
Uppsala, Sweden

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Lars Knutson, MD, PhD

Inst för Kirurgiska VetenskaperUppsala Universitet

More Information

No publications provided

Responsible Party:	AstraZeneca R&D Mölndal ( Karin Wåhlander, MSD )
Study ID Numbers:	D1250C00029
Study First Received:	December 19, 2008
Last Updated:	April 1, 2009
ClinicalTrials.gov Identifier:	NCT00812344 History of Changes
Health Authority:	Sweden: Medical Products Agency

Keywords provided by AstraZeneca:

pharmacokinetics

Additional relevant MeSH terms:

Anti-Infective Agents
Therapeutic Uses
Antifungal Agents
Ketoconazole
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010