Safety, Tolerability & PK of AZD0328 in Caucasian & Japanese
- Registration Number
- NCT00738959
- Lead Sponsor
- AstraZeneca
- Brief Summary
This study will be performed to evaluate the safety, tolerability and pharmacokinetics of single and multiple doses of AZD0328 when administered to Japanese and Caucasian healthy male volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 64
Inclusion Criteria
- first generation Japanese (both parents and grandparents are Japanese, the subject is born in Japan and left Japan less than 10 years ago) or Caucasian subjects.
- Clinically normal physical findings, laboratory values, vital signs and resting ECG as judged by the investigator.
Exclusion Criteria
- History of clinically significant cardio- or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder or any other major disorder that may interfere with the study.
- Participation in another study within 12 weeks before the first administration of the investigational product.
- Intake of any prescribed medicine or herbal remedies based on St John's Wort, except for occasional paracetamol and nasal adrenergic anticongestants, within 3 weeks before the first administration of the investigational product.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 AZD0328 -
- Primary Outcome Measures
Name Time Method Safety variables (adverse events, vital signs, paper ECGs and 12-lead continuous digital ECGs including QT/QTc interval measurements During the whole treatment period
- Secondary Outcome Measures
Name Time Method PK variables Several samples during the study days
Trial Locations
- Locations (1)
Research Site
🇬🇧London, United Kingdom
Research Site🇬🇧London, United Kingdom