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A First Time in Man, Study to Assess the Safety of AZD8329 After Single Ascending Oral Doses

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00935662
First received: July 7, 2009
Last updated: September 10, 2010
Last verified: September 2010
History of Changes

July 7, 2009
September 10, 2010
July 2009
August 2010   (final data collection date for primary outcome measure)
Safety measurements (ECG's, Pulse, Blood Pressure, Safety Laboratory and Adverse Events) [ Time Frame: Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study. ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00935662 on ClinicalTrials.gov Archive Site
PK samples for AZD8329 [ Time Frame: Intense PK-sampling during the 24 hours following administration of investigational product and additional samples up to 72 hours after dose. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A First Time in Man, Study to Assess the Safety of AZD8329 After Single Ascending Oral Doses
A Randomised, Single-blind, Placebo-controlled, Two-centre Phase I Study in Healthy Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of AZD8329 After Single Ascending Oral Doses

The primary objective for this study is to assess the safety and tolerability of AZD8329 when given as a single dose in increasing dose strength, and also to identify the highest tolerated dose for future studies.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Healthy Men
  • Drug: AZD8329
    Oral solution, single ascending doses
  • Drug: Placebo
    Oral solution, placebo
  • Experimental: AZD8329
    AZD8329 oral solution
    Intervention: Drug: AZD8329
  • Placebo Comparator: Placebo
    Placebo for AZD8329 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
119
August 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Provision of informed consent prior to any study specific procedures
  • Have a body mass index between 19 and 30 kg/m2 and weigh at least 50 kg

Exclusion Criteria:

  • Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the result of the study, or the subject´s ability to participate
  • Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator
  • Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.
Male
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00935662
D2350C00001, EudraCT No. 2009-010702-11
No
MSD, AstraZeneca R&D Mölndal, Sweden
AstraZeneca
Not Provided
Principal Investigator: Wolfgang Kühn Quintiles AB, Phase I Services, Uppsala, Sweden
AstraZeneca
September 2010

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