A Study to Investigate the Effect of Food on Pharmacokinetics of Total EPA and Total DHA of AZD0585 in Healthy Male Japanese Subjects
Study identifier:D5884C00004
ClinicalTrials.gov identifier:NCT02372344
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I, Single Centre, Randomized, Open-Label, Three-Period Crossover Study to Investigate the Effect of Food on Pharmacokinetics of Total EPA and Total DHA with a Single 4 g Dose of AZD0585 in Healthy Male Japanese Subjects
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD0585
Sex
Male
Actual Enrollment
72
Study type
Interventional
Age
20 Years - 45 Years
Date
Study Start Date: 01 Mar 2015
Primary Completion Date: 01 May 2015
Study Completion Date: 01 May 2015
Study design
Allocation: Randomized
Endpoint Classification: Bio-availability
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Apr 2016 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Fasting Each subject will receive a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose will be administered at the end of a 10-hour fast. | Drug: AZD0585 Following an overnight fast of at least 10 hours, a single dose of 4 g AZD0585 will be administered on 3 separate occasions (fasting, before meal, and after meal) in a randomized crossover fashion with different food restrictions. |
| Experimental: Before meal Each subject will receive a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose will be administered before consumption of a low calorie, low-fat breakfast (within 30 minutes before starting food intake). | Drug: AZD0585 Following an overnight fast of at least 10 hours, a single dose of 4 g AZD0585 will be administered on 3 separate occasions (fasting, before meal, and after meal) in a randomized crossover fashion with different food restrictions. |
| Experimental: After meal Each subject will receive a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose will be administered after consumption of a low calorie, low-fat breakfast (within 30 minutes after starting food intake). | Drug: AZD0585 Following an overnight fast of at least 10 hours, a single dose of 4 g AZD0585 will be administered on 3 separate occasions (fasting, before meal, and after meal) in a randomized crossover fashion with different food restrictions. |
Contacts
Investigators
Principal Investigator
Kei Sakamoto
Sugioka Memorial Hospital, Medical Co. LTA
