A Ph1 Study in Healthy Male Japanese and Caucasian After Single and Multiple Doses of D5884(omega-3-carboxylic acids)

Study identifier:D5881C00005

ClinicalTrials.gov identifier:NCT02209766

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics in Healthy Male Japanese (Single-blind, Randomized, Placebo-controlled) and Caucasian (Open-label) Subjects After Single and Once Daily Multiple Oral Doses of D5884

Medical condition

Healthy

Phase

Phase 1

Healthy volunteers

Yes

Study drug

D5884, Placebo

Sex

Male

Actual Enrollment

86

Study type

Interventional

Age

20 Years - 45 Years

Date

Study Start Date: 01 Aug 2014
Primary Completion Date: 01 Nov 2014
Study Completion Date: 01 Nov 2014

Study design

Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Basic Science

Verification:

Verified 01 Apr 2016 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria