At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 72 enrolled
Drug / intervention
AZD0585drug
Likely dose
AZD0585 4 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating AZD0585 for Healthy. Completed, enrolled 72 participants across 1 site.
Detailed Summary
The purpose of this study is to assess the effect of food timing on pharmacokinetics (PK) of AZD0585 and the effect of food timing on tolerability and safety of AZD0585 in healthy male Japanese subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesJapan
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 2015
Enrollment StartMar 2015
Primary CompletionMay 2015
TodayJul 2026
First PostedFeb 26, 2015
Enrollment StartMar 1, 2015
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 11.3 years ago
Interventions
AZD0585drug
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.