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

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00687141
• Other study ID #: D0190C00006
• Secondary ID: EudractCT 2007-0
• Status: Completed
• Phase: Phase 1
• First received: May 28, 2008
• Last updated: December 8, 2010
• Start date: November 2007
• Est. completion date: June 2008

Study information

• Verified date: July 2008
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencySweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

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

Locations

Country	Name	City	State
Sweden	Research Site	Linkoping
Sweden	Research Site	Lulea
Sweden	Research Site	Stockholm
Sweden	Research Site	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Primary	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.	Yes
Secondary	Determine the single and multiple dose pharmacokinetics (PK) of AZD0328		PK sampling taken at defined timepoints during residential period.	No
Secondary	Evaluate the cognitive dose response relationship for AZD0328		Psychometric test battery performed at defined timepoints during residential period.	No