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

Primary Purpose

Alzheimer's Disease

Status

Completed

Phase

Phase 1

Locations

Sweden

Study Type

Interventional

Intervention

AZD0328

Placebo

About this trial

This is an interventional basic science trial for Alzheimer's Disease focused on measuring Safety, tolerability, AZD0328

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Research Site
Research Site
Research Site
Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Safety and tolerability of AZD0328 by assessment of vital signs, laboratory variables and ECG

Safety and tolerability of AZD0328 by assessment of adverse events

Secondary Outcome Measures

Determine the single and multiple dose pharmacokinetics (PK) of AZD0328

Evaluate the cognitive dose response relationship for AZD0328

Full Information

NCT ID

NCT00687141

First Posted

May 28, 2008

Last Updated

December 8, 2010

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00687141

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2008

Overall Recruitment Status

Completed

Study Start Date

November 2007 (undefined)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

AstraZeneca

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease

Keywords

Safety, tolerability, AZD0328

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

112 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

AZD0328

Intervention Description

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

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

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.

Title

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.

Secondary Outcome Measure Information:

Title

Determine the single and multiple dose pharmacokinetics (PK) of AZD0328

Time Frame

PK sampling taken at defined timepoints during residential period.

Title

Evaluate the cognitive dose response relationship for AZD0328

Time Frame

Psychometric test battery performed at defined timepoints during residential period.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wolfgang Kühn

Organizational Affiliation

Quintiles ABStrandbodgatan 1S-753 23 Uppsala

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Erik Eliasson, MD, PhD

Organizational Affiliation

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

Official's Role

Study Chair

Facility Information:

Facility Name

Research Site

City

Linkoping

Country

Sweden

Facility Name

Research Site

City

Lulea

Country

Sweden

Facility Name

Research Site

City

Stockholm

Country

Sweden

Facility Name

Research Site

City

Uppsala

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

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

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