Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of AZD8566.
- Registration Number
- NCT00844103
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to determine how well tolerated and safe AZD8566 is when given over 10 days, at different dose levels. This study will also determine how AZD8566 is distributed around the body and how it leaves the body.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
- Provision of written informed consent.
- Clinically normal physical findings and laboratory values as judged by the investigator with normal ECG
- Females who are permanently or surgically sterile or postmenopausal and males.
Exclusion Criteria
- Intake of medicine (except Hormone Replacement Therapy or occasional paracetamol) within 3 weeks before first administration of study drug
- History of any convulsions or seizures
- History of infection or at risk of infection due to recent surgery or trauma
- History or presence of conditions known to interfere with the absorption, distribution, metabolism and excretion of the study drug
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Placebo - 1 AZD8566 -
- Primary Outcome Measures
Name Time Method Pharmacokinetic profile: concentration of AZD8566 in blood Samples taken during Visit 2 (residential period) at up to 15 defined timepoints pre-dose and post- dose on Day 1 and Day 10 Safety and tolerability of AZD8566 by assessment of vital signs, laboratory variables, ECG and adverse events Assessments taken at Visit 1 (enrolment), defined timepoints pre-dose and post-dose during Visit 2 (residential period) and at Visit 3 (follow up). Volunteers will be monitored throughout the study from Visit 1 to Visit 3 for adverse events.
- Secondary Outcome Measures
Name Time Method Pharmacokinetic profile: concentration of AZD8566 in urine Samples collected over 48 hours from pre-dose to 48 hours post-dose on Day 1 and Day 10.
Trial Locations
- Locations (1)
Research Site
🇬🇧Macclesfield, Cheshire, United Kingdom