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Sponsored by: |
AstraZeneca |
Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00687141 |
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 I |
Genetics Home Reference related topics: | Alzheimer disease |
MedlinePlus related topics: | Alzheimer's Disease |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study |
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 |
Enrollment: | 112 |
Study Start Date: | November 2007 |
Study Completion Date: | July 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental |
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.
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2: Placebo Comparator |
Drug: Placebo
Administered orally as a solution once per day on day 1, and then day 3 through to day 14.
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Ages Eligible for Study: | 60 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Sweden | |||||
Research Site | |||||
UPPSALA, Sweden | |||||
Research Site | |||||
LULEA, Sweden | |||||
Research Site | |||||
LINKOPING, Sweden | |||||
Research Site | |||||
STOCKHOLM, Sweden |
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 |
Responsible Party: | AstraZeneca Pharmaceuticals ( Didier Meulien, M.D., Medical Science Director, Emerging Neuroscience ) |
Study ID Numbers: | D0190C00006, EudractCT 2007-004598-25 |
First Received: | May 28, 2008 |
Last Updated: | July 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00687141 |
Health Authority: | Sweden: Medical Products Agency; Sweden: Regional Ethical Review Board |
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