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AZD6088 Single Ascending Dose Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00931541
Recruitment Status : Completed
First Posted : July 2, 2009
Last Update Posted : September 10, 2009
Sponsor:
Information provided by:

June 30, 2009
July 2, 2009
September 10, 2009
June 2009
Not Provided
Safety variables (vital signs, ECG, EEG, safety laboratory values, body temp) [ Time Frame: Sampling occasions during all visits. ]
Same as current
Complete list of historical versions of study NCT00931541 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics [ Time Frame: Intense PK-sampling during 3 pre-defined study days for PK profiling. ]
  • Pharmacodynamics [ Time Frame: Sampling occasions during 3 pre-defined study days. ]
Same as current
Not Provided
Not Provided
 
AZD6088 Single Ascending Dose Study
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Healthy Volunteers
  • Drug: AZD6088
    Oral solution. Each subject will receive a single-dose of AZD6088.
  • Drug: Placebo
    Oral solution. Each subject will receive a single-dose of placebo.
  • Experimental: A
    AZD6088 oral solution
    Intervention: Drug: AZD6088
  • Experimental: B
    Placebo oral solution
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
August 2009
Not Provided

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00931541
D0840C00007
EudraCT N0. 2008-007936-17
No
Not Provided
Not Provided
MSD, AstraZeneca
AstraZeneca
Not Provided
Study Director: Biljana Lilja AstraZeneca R&D, Södertälje, Sweden
Principal Investigator: Marianne Kasti Quintiles GDRU, London, UK
AstraZeneca
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP