AZD7325 Single Ascending Dose Study in Healthy Male Japanese Subjects
- Registration Number
- NCT00769899
- Lead Sponsor
- AstraZeneca
- Brief Summary
This is a Phase I randomized double-blind, placebo-controlled, single centre study to assess the safety, tolerability and pharmacokinetics of AZD7325 following single ascending dose administration to healthy male Japanese volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 48
Inclusion Criteria
- Body mass index (BMI) : 18 to 27 kg/m 2
Exclusion Criteria
- Clinically relevant disease and/or abnormalities (past or present)
- Clinically relevant abnormalities in physical examinations,vital signs,clinical chemistry, hematology or urinalysis at screening as judged by the investigator
- Use of any medication or herbal preparation within 14 days of Study day 1 through the Follow-up Visit other than paracetamol (up to 3 g/day)
- Smoking in excess of 5 cigarettes per day or the equivalent within 28 days prior to the first study day or inability to refrain from smoking during the study confinement period
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Placebo - 1 AZD7325 -
- Primary Outcome Measures
Name Time Method Safety and tolerabilityThe nature and incidence of adverse events (AEs), vital signs,physical examinations,electrocardiograms (ECGs)and laboratory assessments. During the study
- Secondary Outcome Measures
Name Time Method Pharmacokinetic parameters for AZD7325 During residential period Genetic analysis of the genes involved in the pharmacokinetics and safety and tolerability to AZD7325 treatment may be performed. Participation in the exploratory genetic study is optional for the subjects. During the study
Trial Locations
- Locations (1)
Research Site
🇺🇸Baltimore, Maryland, United States