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

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

This study has been completed.

Study NCT00687141. Last updated on July 10, 2008. Information provided by AstraZeneca

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

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

Brief Summary

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.

Detailed Description

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study

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 ]

Secondary Outcome Measure ^†

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 ]

Condition ^†

Alzheimer's Disease

Intervention ^†

Drug: AZD0328
Drug: Placebo

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

112

Start Date ^†

November 2007

Completion Date

July 2008

Eligibility 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

Gender

Both

Ages

60 Years to 80 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Sweden

Administrative Information Fields

NCT ID ^†

NCT00687141

Organization ID

D0190C00006

Secondary IDs ^††

EudractCT 2007-004598-25

Study Sponsor ^†

AstraZeneca

Collaborators ^††

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

Information Provided By

AstraZeneca

Verification Date

July 2008

First Received Date ^†

May 28, 2008

Last Updated Date

July 10, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.