AZD3355 Dose-escalation Study in Healthy Males
- Registration Number
- NCT00757419
- Lead Sponsor
- AstraZeneca
- Brief Summary
The aim is to establish the maximal tolerated dose of AZD3355 for the selection of doses in the up-coming studies. This will be done by comparing single and repeated doses of AZD3355 to placebo ("inactive substance"). Safety and tolerability variables will be closely monitored throughout the study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 54
Inclusion Criteria
- Subjects without concurrent diseases who do not require any medical treatments
- Provision of signed informed consent.
Exclusion Criteria
- History of somatic disease/condition, which may interfere with the objectives for the study, as judged by the investigator.
- Clinically significant illness or clinically relevant trauma within the 2 weeks prior to the administration of the investigational product, as judged by the investigator.
- History of clinically significant orthostatic reaction or syncope
- Clinically important abnormalities related to the heart function
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 AZD3355 - 2 Placebo -
- Primary Outcome Measures
Name Time Method Safety variables (Adverse event reporting, ECG, blood pressure, pulse rate, urine weight and osmolality, body temperature, blood and urine laboratory values) During the study
- Secondary Outcome Measures
Name Time Method Pharmacokinetic variables Several occasions during the study days
Trial Locations
- Locations (1)
Research Site
πΈπͺGothenburg, Sweden