Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Anti-Infective Agents
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014