Effect of ketoconazole on biliary excretion of AZD0837
Study identifier:D1250C00029
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
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
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD0837, Ketoconazole, ketoconazole
Sex
Male
Actual Enrollment
20
Study type
Interventional
Age
18 Years - 45 Years
Date
Study Start Date: 01 Dec 2008
Primary Completion Date: 01 Mar 2009
Study Completion Date: 01 Mar 2009
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Other
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| 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 |
Contacts
Investigators
Principal Investigator
Lars Knutson
Inst för Kirurgiska VetenskaperUppsala Universitet
