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

NCT ID: NCT00687141

Last Updated: 2010-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-06-30

Brief Summary

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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

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Conditions

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Alzheimer's Disease

Keywords

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Safety tolerability AZD0328

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

AZD0328

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally as a solution once per day on day 1, and then day 3 through to day 14.

Interventions

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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.

Intervention Type DRUG

Placebo

Administered orally as a solution once per day on day 1, and then day 3 through to day 14.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca Pharmaceuticals

Principal Investigators

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Wolfgang Kühn

Role: PRINCIPAL_INVESTIGATOR

Quintiles ABStrandbodgatan 1S-753 23 Uppsala

Erik Eliasson, MD, PhD

Role: STUDY_CHAIR

AstraZeneca R&D SödertäljeMedical Science S-151 85 Södertälje Sweden

Locations

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Research Site

Linköping, , Sweden

Site Status

Research Site

Luleå, , Sweden

Site Status

Research Site

Stockholm, , Sweden

Site Status

Research Site

Uppsala, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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EudractCT 2007-004598-25

Identifier Type: -

Identifier Source: secondary_id

D0190C00006

Identifier Type: -

Identifier Source: org_study_id