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Effect of Ketoconazole on Biliary Excretion of AZD0837

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00812344
First received: December 19, 2008
Last updated: December 2, 2010
Last verified: December 2010
History of Changes
  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 1

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

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: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD0837
Oral solution, dosing through the Loc-I-Gut catheter, single dose
Active Comparator: 2
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: Karin Wåhlander, MSD, AstraZeneca R&D Mölndal
ClinicalTrials.gov Identifier: NCT00812344     History of Changes
Other Study ID Numbers: D1250C00029
Study First Received: December 19, 2008
Last Updated: December 2, 2010
Health Authority: Sweden: Medical Products Agency

Keywords provided by AstraZeneca:
pharmacokinetics

Additional relevant MeSH terms:
Ketoconazole
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013