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Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD0328 in Elderly Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00687141
First received: May 28, 2008
Last updated: December 8, 2010
Last verified: July 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
 Drug: AZD0328
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 112
Study Start Date: November 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD0328
Oral solution administered orally once per day on day 1, and then day 3 through to day 14. Specific dose depends on dose panel.
Placebo Comparator: 2 Drug: Placebo
Administered orally as a solution once per day on day 1, and then day 3 through to day 14.

  Eligibility

Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00687141

Locations
Sweden
Research Site
Linkoping, Sweden
Research Site
Lulea, Sweden
Research Site
Stockholm, Sweden
Research Site
Uppsala, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
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
  More Information

No publications provided

Responsible Party: Didier Meulien, M.D., Medical Science Director, Emerging Neuroscience, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00687141     History of Changes
Other Study ID Numbers: D0190C00006, EudractCT 2007-004598-25
Study First Received: May 28, 2008
Last Updated: December 8, 2010
Health Authority: Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board

Keywords provided by AstraZeneca:
Safety
tolerability
AZD0328

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013