Study identifier:D0475C00004
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase I, Single-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics after Multiple Oral Doses of AZD2066 in Japanese Healthy Male Subjects
Healthy
Phase 1
Yes
AZD2066, Placebo
Male
132
Interventional
20 Years - 45 Years
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
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No locations available
Arms | Assigned Interventions |
---|---|
Experimental: 1 4 dose panels receiving a specified volume of AZD2066 oral solution once daily for 11 days | Drug: AZD2066 Oral solution administered orally once per day on day 1, and then day 3 through to day 12 for the first and second dose panels and day 5 through to day 14 for the third and fourth dose panels. For the fifth and sixth panels, oral solution administered once per day on day 1, and then day 5 through to day 16. Specific dose depends on dose panel. |
Placebo Comparator: 2 Included in each dose panel | Drug: Placebo Oral solution administered orally once per day on day 1, and then day 3 through to day 12 for the first and second dose panels and day 5 through to day 14 for the third and fourth dose panels. For the fifth and sixth panels, oral solution administered once per day on day 1, and then day 5 through to day 16. |