Status:
COMPLETED
AZD2423 Single Ascending Dose Study in Healthy Japanese Subjects
Lead Sponsor:
AstraZeneca
Conditions:
Healthy Volunteer
Eligibility:
All Genders
20-55 years
Phase:
PHASE1
Brief Summary
This is a Phase I, single centre, randomised, double-blind, placebo-controlled, parallel group study to assess the safety, tolerability and pharmacokinetics of AZD2423 following single ascending dose ...
Eligibility Criteria
Inclusion
- Healthy Japanese male and non-fertile female subjects aged ≥20 to ≤55 years with suitable veins for cannulation or repeated venepuncture.
- Body weight 45-90 kg and Body mass index (BMI) ≥18.0 and ≤27.0 kg/m2
- Clinically normal physical findings including supine blood pressure, pulse rate, orthostatic blood pressure, ECG, and laboratory assessments in relation to age, as judged by the Investigator.
Exclusion
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- Any clinically significant illness/infection or medical/surgical procedure or trauma, as judged by the Principal Investigator, within 3 months of the first administration of investigational product.
- Frequent use of tobacco or other nicotine containing products. Frequent use is defined as smoking or consumption/intake of nicotine products more than two days per week during the last 12 weeks.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00970775
Start Date
August 1 2009
End Date
December 1 2009
Last Update
March 18 2010
Active Locations (2)
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1
Research Site
Croydon, United Kingdom
2
Research Site
London, United Kingdom