AZD6088 Single Ascending Dose Study
- Registration Number
- NCT00931541
- Lead Sponsor
- AstraZeneca
- Brief Summary
The aims of the study are to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD6088 following single ascending dose administration in healthy male and non-fertile females.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
- Caucasian male and non-fertile female healthy volunteers aged ≥18 to ≤55 years with suitable veins for cannulation or repeated venipuncture.
- Clinically normal physical findings including supine BP, pulse rate, ECG and laboratory assessments in relation to age, as judged by the investigator.
- Normal and suitable EEG, as judged by a neurologist
Exclusion Criteria
- History of any clinically significant disease or disorder which for instance includes CNS disorder or CV disorder.
- Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator.
- Any clinically important abnormalities in the ECG.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A AZD6088 AZD6088 oral solution B Placebo Placebo oral solution
- Primary Outcome Measures
Name Time Method Safety variables (vital signs, ECG, EEG, safety laboratory values, body temp) Sampling occasions during all visits.
- Secondary Outcome Measures
Name Time Method Pharmacokinetics Intense PK-sampling during 3 pre-defined study days for PK profiling. Pharmacodynamics Sampling occasions during 3 pre-defined study days.
Trial Locations
- Locations (1)
Research Site
🇬🇧London Bridge, Greater London, United Kingdom
Research Site🇬🇧London Bridge, Greater London, United Kingdom