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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00687141

Collaborator

(none)

112

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer's Disease	Drug: AZD0328 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

112 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

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 Start Date :

Nov 1, 2007

Actual Primary Completion Date :

Jun 1, 2008

Actual Study Completion Date :

Jun 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	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.
Placebo Comparator: 2	Drug: Placebo Administered orally as a solution once per day on day 1, and then day 3 through to day 14.

Arm

Intervention/Treatment

Experimental: 1

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.

Placebo Comparator: 2

Drug: Placebo

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

Outcome Measures

Primary Outcome Measures

Safety and tolerability of AZD0328 by assessment of vital signs, laboratory variables and ECG [Assessments taken at visit 1 (enrolment), during visit 2 (residential period) and follow up visit 3.]
Safety and tolerability of AZD0328 by assessment of adverse events [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 Measures

Determine the single and multiple dose pharmacokinetics (PK) of AZD0328 [PK sampling taken at defined timepoints during residential period.]
Evaluate the cognitive dose response relationship for AZD0328 [Psychometric test battery performed at defined timepoints during residential period.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	Country
1	Research Site	Linkoping	Sweden
2	Research Site	Lulea	Sweden
3	Research Site	Stockholm	Sweden
4	Research Site	Uppsala	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00687141

Other Study ID Numbers:

D0190C00006
EudractCT 2007-004598-25

First Posted:

May 30, 2008

Last Update Posted:

Dec 10, 2010

Last Verified:

Jul 1, 2008

Keywords provided by , ,

Safety

tolerability

AZD0328

Additional relevant MeSH terms:

Alzheimer Disease

Study Results

No Results Posted as of Dec 10, 2010