AZD5423 Single Ascending Dose Study
- Registration Number
- NCT00963183
- Lead Sponsor
- AstraZeneca
- Brief Summary
The aim of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5423 following single ascending dose administrations in healthy male subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 72
Inclusion Criteria
- Provision of signed, written and dated informed consent prior to any study specific procedures
- Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
Exclusion Criteria
- Any clinically significant disease or disorder
- Any clinically significant abnormalities at screening examination
- Use of any prescribed or non-prescribed medication
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B Placebo Drug: Placebo A AZD5423 Drug: AZD5423
- Primary Outcome Measures
Name Time Method Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab), lung function and physical examination Frequent sampling occasions during study days
- Secondary Outcome Measures
Name Time Method Pharmacokinetics - Maximum plasma concentration (Cmax), time to Cmax (tmax), area under the plasma concentration-time curve from zero to the time of the last measurable concentration [AUC(0-t)] and from zero to infinity (AUC) Frequent sampling occasions during study days Add'l pharmacokinetics - Terminal rate constant (λz); terminal half-life (t½λz), Apparent plasma clearance (CL/F), apparent volume of distribution during terminal phase (Vz/F), mean residence time (MRT). Frequent sampling occasions during study days Pharmacodynamics - Plasma cortisol concentrations Frequent sampling occasions during study days
Trial Locations
- Locations (1)
Research Site
🇬🇧London, United Kingdom