AZD8529 Single Ascending Dose Study in Healthy Japanese Subjects
- Registration Number
- NCT00886756
- Lead Sponsor
- AstraZeneca
- Brief Summary
This is a Phase I, double-blind, placebo-controlled, randomised within each dose group, single ascending dose study, with the objective to assess the safety, tolerability and pharmacokinetic profile of AZD8529 in healthy Japanese subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 48
Inclusion Criteria
- Healthy male Japanese subjects aged 20 to 45 years (inclusive)
- Have a body mass index (BMI) between 18 and 27 kg/m 2 (inclusive) and weigh at least 50 kg.least 50 kg.
Exclusion Criteria
- 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 relevant abnormalities in physical examinations, vital signs, clinical chemistry, haematology or urinalysis as judged by the Investigator and/or Sponsor.
- Smoking in excess of 5 cigarettes per day or the equivalent within 28 days of Day 1.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Placebo - 1 AZD8529 -
- Primary Outcome Measures
Name Time Method To asses the safety:Adverse events, vital signs, physical examinations, telemetry, dECGs, clinical chemistry and haematology labs including testosterone, prolactin, LH, FSH and TSH, and urinalysis. From screening period to follow-up, 42 days (maiximum).
- Secondary Outcome Measures
Name Time Method To characterize the pharmacokinetics of AZD8529 in plasma and urine. Blood and urine sampling from pre-dose until 12 days post dose. To collect and store DNA for future exploratory research One blood sampling after randomisation.
Trial Locations
- Locations (1)
Research Site
🇬🇧London, United Kingdom