AZD6088 Single Ascending Dose Study
This study has been completed.
Information provided by:
First received: June 30, 2009
Last updated: September 9, 2009
Last verified: September 2009
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
|Official Title:||A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral AZD6088 After Single Ascending Doses in Healthy Male and Non-Fertile Female Volunteers|
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Safety variables (vital signs, ECG, EEG, safety laboratory values, body temp) [ Time Frame: Sampling occasions during all visits. ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pharmacokinetics [ Time Frame: Intense PK-sampling during 3 pre-defined study days for PK profiling. ] [ Designated as safety issue: No ]
- Pharmacodynamics [ Time Frame: Sampling occasions during 3 pre-defined study days. ] [ Designated as safety issue: No ]
|Study Start Date:||June 2009|
|Study Completion Date:||August 2009|
AZD6088 oral solution
Oral solution. Each subject will receive a single-dose of AZD6088.
Placebo oral solution
Oral solution. Each subject will receive a single-dose of placebo.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00931541
|London Bridge, Greater London, United Kingdom|
Sponsors and Collaborators
|Study Director:||Biljana Lilja||AstraZeneca R&D, Södertälje, Sweden|
|Principal Investigator:||Marianne Kasti||Quintiles GDRU, London, UK|