Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of AZD8566.
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
|Official Title:||A Phase I, Randomised, Double Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Oral Doses of AZD8566 in Healthy Volunteers|
- Pharmacokinetic profile: concentration of AZD8566 in blood [ Time Frame: Samples taken during Visit 2 (residential period) at up to 15 defined timepoints pre-dose and post- dose on Day 1 and Day 10 ] [ Designated as safety issue: No ]
- Safety and tolerability of AZD8566 by assessment of vital signs, laboratory variables, ECG and adverse events [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
- Pharmacokinetic profile: concentration of AZD8566 in urine [ Time Frame: Samples collected over 48 hours from pre-dose to 48 hours post-dose on Day 1 and Day 10. ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Study Completion Date:||April 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
10ml oral solution administered once a day over 10 days. Specific dose will be selected by the safety review committee
|Placebo Comparator: 2||
10ml oral solution administered once a day over 10 days.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00844103
|Macclesfield, Cheshire, United Kingdom|
|Principal Investigator:||Emeline Ramos, MD||Clinical Pharmacology Unit|