AZD6088 Single Ascending Dose Study

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00931541
First received: June 30, 2009
Last updated: September 9, 2009
Last verified: September 2009

June 30, 2009
September 9, 2009
June 2009
Not Provided
Safety variables (vital signs, ECG, EEG, safety laboratory values, body temp) [ Time Frame: Sampling occasions during all visits. ] [ Designated as safety issue: Yes ]
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. ] [ Designated as safety issue: No ]
  • Pharmacodynamics [ Time Frame: Sampling occasions during 3 pre-defined study days. ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00931541
D0840C00007, EudraCT N0. 2008-007936-17
No
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