Study to Assess Safety, Tolerability and Pharmacokinetics After Single Dose of AZD2516 to Japanese Healthy Subjects
- Registration Number
- NCT00972049
- Lead Sponsor
- AstraZeneca
- Brief Summary
The primary purpose of this study is to assess the safety and tolerability of AZD2516 following administration of a single dose to Japanese healthy subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Weight between 45 to 100 kg and a body mass index (BMI) between 19 to 28 kg/m2
- Japanese males aged between 20 to 45 years old (young) and Japanese males or females aged between 65 to 80 years old (elderly)
Exclusion Criteria
- History of previous or ongoing somatic or psychiatric disease/condition
- Abnormalities in ECG that may interfere with interpretation of data.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 AZD2516 Capsule administered once orally 2 Placebo Capsule administered once orally
- Primary Outcome Measures
Name Time Method Safety and tolerability of AZD2516 in Japanese healthy subjects by assessment of adverse events, vital signs, laboratory variables and ECG Assessments taken at visit 1 (enrolment), defined time points pre dose and post dose during visit 2 (residential period): days -1 through to day 3 and follow up visit 3
- Secondary Outcome Measures
Name Time Method Investigate the single ascending dose pharmacokinetics of AZD2516 in Japanese subjects Blood sampling at defined timepoints during residential period and follow-up
Trial Locations
- Locations (1)
Research Site
🇯🇵Fukuoka, Japan