AZD0837 Extended Release (ER) Japan Study
- Registration Number
- NCT00904800
- Lead Sponsor
- AstraZeneca
- Brief Summary
This phase I study will evaluate safety and tolerability after repeated doses of AZD0837.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 36
Inclusion Criteria
- Healthy male Japanese subject aged between 20 to 45 years inclusive
Exclusion Criteria
- Acute illness (including ongoing or history of liver disease), trauma or surgical procedures within two weeks before Visit 1 or pre first dose in Visit 2
- Intake of another investigational drug within 4 months before Visit 1 or pre first dose in Visit 2
- Blood donation and/or sampling in excess of 200 mL of whole blood within the preceding 4 weeks, 400 mL of whole blood within the preceding 12 weeks and/or 1200 mL of whole blood within the preceding 12 months, before Visit 1 or pre first dose in Visit 2
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 AZD0837 Low dose 2 AZD0837 Middle dose 3 AZD0837 High dose 4 Placebo placebo
- Primary Outcome Measures
Name Time Method To investigate the safety and tolerability of AZD0837 after single and repeated oral dosing of AZD0837 extended release (ER) tablet, in Japanese healthy subjects. All assessments are made at each visit, at least daily, during the study.
- Secondary Outcome Measures
Name Time Method To investigate the pharmacokinetics (PK) of AZD0837, AR H069927XX and AR-H067637XX after single and repeated oral dosing of AZD0837 ER tablet, in Japanese healthy subjects. Blood samples will be taken before and after study drug administration.
Trial Locations
- Locations (1)
Research Site
🇯🇵Kagoshima, Japan