Effect of Ketoconazole on Biliary Excretion of AZD0837
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: AZD0837 (Drug); Ketoconazole (Drug); ketoconazole (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Lars Knutson, MD, PhD, Principal Investigator, Affiliation: Inst för Kirurgiska VetenskaperUppsala Universitet
Overall contact:
AstraZeneca Clinical Study Information, Phone: 800-236-9933, Email: information.center@astrazeneca.com
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
Clinical Details
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
Study design: Other, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
Primary outcome: Amount of AZD0837, AR-H069927XX, and AR-H067637XX in bile and biliary clearance of AZD0837, AR-H069927XX, and AR-H067637XX.
Secondary outcome: PK variables of AZD0837, AR-H069927XX, and AR-H067637XX.Adverse events, physical examination, safety laboratory variables, blood pressure, pulse and electrocardiography. Pharmacogenetics
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Male.
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
Locations and Contacts
AstraZeneca Clinical Study Information, Phone: 800-236-9933, Email: information.center@astrazeneca.com
Research Site, Uppsala, Sweden; Recruiting
Additional Information
Starting date: December 2008
Ending date: April 2009
Last updated: January 12, 2009
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