Study identifier:D3550C00011
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
An open-label, fixed-sequence, single-centre phase I study to assess the effect of ketoconazole on the pharmacokinetics of AZD5069 after oral administration of a single dose AZD5069 to healthy male volunteers
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Phase 1
Yes
AZD5069, Ketoconazole
Male
15
Interventional
18 Years - 50 Years
Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verified 01 Jun 2015 by AstraZeneca
AstraZeneca
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The main purpose of the study is to compare the change of the AZD5069 Pharmacokinetic profile when administered with ketoconazole. Subjects will be treated first with AZD5069 only followed by a washout period before starting with the combined treatment (both ketoconazole and AZD5069).
An open-label, fixed-sequence, single-centre phase I study to assess the effect of ketoconazole on the pharmacokinetics of AZD5069 after oral administration of a single dose AZD5069 to healthy male volunteers
Location
Location
London, United Kingdom
Arms | Assigned Interventions |
---|---|
Experimental: First AZD5069, then Ketoconazole + AZD5069 AZD5069 in first period (on 1 day) and in second period (after wash out) ketoconazole alone (on 2 days) then ketoconazole + AZD5069 (on 1 day), then again ketoconazole alone (on 2 days) | Drug: AZD5069 AZD5069 15 mg (3x5 mg capsules) single administration Drug: Ketoconazole Ketoconazole 400 mg (2x200 mg tablets) |
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