AZD8529 Single Ascending Dose Study
- Registration Number
- NCT00755378
- Lead Sponsor
- AstraZeneca
- Brief Summary
This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD8529 after single ascending doses
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
Inclusion Criteria
- Healthy male or female subjects aged 18 to 45 years (inclusive) on Day 1. Female subjects must be of non-child bearing potential.
Exclusion Criteria
- Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 3 months of the first administration of investigational prod
- Plasma donation within one month of screening or any blood donation/blood loss > 500mL during the 3 months prior to screening
- Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 AZD8529 - 2 Placebo -
- Primary Outcome Measures
Name Time Method To assess the safety and tolerability of single dose administration of AZD8529 when given orally to healthy male subjects and female subjects of non-childbearing potential. at each visit, at least daily, during the study.
- Secondary Outcome Measures
Name Time Method To asses the effect of food on the safety and pharmacokinetic profile of AZD8529. Safety assessments and blood and urine samples will be taken throughout the study. To characterize the pharmacokinetics of AZD8529 in plasma and urine. Blood and urine samples will be taken during the study.
Trial Locations
- Locations (1)
Research Site
🇺🇸Philadelphia, Pennsylvania, United States