Study to Investigate Safety and Tolerability Single Ascending Doses of AZD4017.
The primary aim of this study is to investigate the safety and tolerabilty of AZD4017 when given as single oral ascending doses to Japanese healthy male volunters. This will be done by comparing the effect of AZD4017 to placebo. The study will aslo investigate the absorption, distrubution and disappearance of AZD4017 in the body. Information about plasma concentrations of AZD4017 vs time after dose intake will also be collected. The future indication for AZD4017 is planned to be Type 2 Diabetes Mellitus.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
|Official Title:||A Randomised, Single-Blind, Placebo-Controlled, Single-Centre Phase I Study in Healthy Japanese Male Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of AZD4017 After Single Ascending Oral Doses|
- Safety and Tolerability (Adverse events, vital signs, ECGs, physical examination, laboratory variables [ Time Frame: The variables will be measure predose and the repeatedly during the following 47 hours after dosing ] [ Designated as safety issue: Yes ]
- Maximum plasma concentration (Cmax), time to Cmax (tmax), terminal half-life, area under the plasma concentration-time curve and the apparent oral plasma clearance (CL/F) [ Time Frame: Blood samples for determination of AZD4017 concentartion will be taken predose and repeatedly during the 47 hours post dose ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2008|
|Study Completion Date:||April 2009|
AZD4017 in ascending doses (start dose 2mg)
ascending single doses (start dose 2 mg), oral suspension
Placebo Comparator: 2
Please refer to this study by its ClinicalTrials.gov identifier: NCT00799747
|Principal Investigator:||Shunji Matsuki||Kyusyu Clinical Phramacology Research Clinic|