Status:
COMPLETED
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Modified-Release Formulations of AZD1446 After Oral Single and Repeated Doses
Lead Sponsor:
AstraZeneca
Conditions:
Healthy
Eligibility:
All Genders
20-80 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess safety, tolerability and pharmacokinetics of AZD1446 in young and elderly healthy Japanese volunteers.
Eligibility Criteria
Inclusion
- Healthy Japanese volunteers, aged ≥20 to ≤50 years for male young volunteers, ≥65 to ≤80 years for male or post-menopausal female elderly volunteers.
- BMI between 18 and 27 kg/m2 and weigh at least 50 kg and no more than 90 kg (for the elderly female, weigh at least 45 kg and no more than 90 kg).
Exclusion
- History of severe allergy/hypersensitivity reactions including drug-allergy or drug hypersensitivity reactions, or ongoing allergy/hypersensitivity.
- History or present symptoms or signs of Quincke oedema, angiooedema, or urticaria pigmentosa, or history of repeated episodes of urticaria.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01199315
Start Date
September 1 2010
End Date
December 1 2010
Last Update
February 17 2011
Active Locations (1)
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1
Research Site
Fukuoka, Fukuoka, Japan