Full Text View
Tabular View
No Study Results Posted
Related Studies
Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD0328 in Elderly Healthy Subjects
This study has been completed.
Study NCT00687141   Information provided by AstraZeneca
First Received: May 28, 2008   Last Updated: July 10, 2008   History of Changes

May 28, 2008
July 10, 2008
November 2007
June 2008   (final data collection date for primary outcome measure)
  • Safety and tolerability of AZD0328 by assessment of vital signs, laboratory variables and ECG [ Time Frame: Assessments taken at visit 1 (enrolment), during visit 2 (residential period) and follow up visit 3. ] [ Designated as safety issue: Yes ]
  • Safety and tolerability of AZD0328 by assessment of adverse events [ Time Frame: Non serious adverse events will be collected from the start of residential period until the end of the study. Serious adverse events will be collected from signing of consent until end of study. ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00687141 on ClinicalTrials.gov Archive Site
  • Determine the single and multiple dose pharmacokinetics (PK) of AZD0328 [ Time Frame: PK sampling taken at defined timepoints during residential period. ] [ Designated as safety issue: No ]
  • Evaluate the cognitive dose response relationship for AZD0328 [ Time Frame: Psychometric test battery performed at defined timepoints during residential period. ] [ Designated as safety issue: No ]
Same as current
 
Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD0328 in Elderly Healthy Subjects
A Phase I, Randomized, Double-Blind (With-in Panel), Placebo-Controlled, Parallel Group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD0328 in Healthy Elderly Volunteers After Oral Multiple Ascending Doses of AZD0328

The primary purpose of this study is to investigate the safety and tolerability of AZD0328 following once-daily dosing for 13 days in elderly healthy volunteers and to define maximum tolerated dose.

 
Phase I
Interventional
Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study
Alzheimer's Disease
  • Drug: AZD0328
  • Drug: Placebo
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
112
July 2008
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Provision of signed informed consent
  • Clinically normal physical findings, laboratory values, vital signs and resting ECG as judged by the investigator

Exclusion Criteria:

  • History of clinically significant cardio- or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder or any other major disorder
  • History of severe allergy/hypersensitivity or symptoms/signs of ongoing allergy/hypersensitivity
  • Intake of any prescribed medicine or St John's Wort, except for occasional paracetamol and nasal anticongestant, within 3 weeks or use of over-the-counter drugs within 2 weeks before the first administration of study drug
Both
60 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00687141
Didier Meulien, M.D., Medical Science Director, Emerging Neuroscience, AstraZeneca Pharmaceuticals
D0190C00006, EudractCT 2007-004598-25
AstraZeneca
 
Principal Investigator: Wolfgang Kühn Quintiles ABStrandbodgatan 1S-753 23 Uppsala
Study Chair: Erik Eliasson, MD, PhD AstraZeneca R&D SödertäljeMedical Science S-151 85 Södertälje Sweden
AstraZeneca
July 2008

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