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

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 I

Genetics Home Reference related topics:

Alzheimer disease

MedlinePlus related topics:

Alzheimer's Disease

U.S. FDA Resources

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

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:	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.
2: Placebo Comparator	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
	UPPSALA, Sweden
	Research Site
	LULEA, Sweden
	Research Site
	LINKOPING, Sweden
	Research Site
	STOCKHOLM, 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

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

Keywords provided by AstraZeneca:

Safety

tolerability

AZD0328

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders

Mental Disorders

Alzheimer Disease

Central Nervous System Diseases

Healthy

Neurodegenerative Diseases

Brain Diseases

Dementia

Cognition Disorders

Delirium

Additional relevant MeSH terms:

Nervous System Diseases

Tauopathies

ClinicalTrials.gov processed this record on October 15, 2008

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00687141