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

Phase 1

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: AZD0328; Drug: Placebo

• Registration Number: NCT00687141
• Lead Sponsor: AstraZeneca

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

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-05-28
• Study First Submitted QC: 2008-05-29
• Study First Posted: 2008-05-30
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2008-07
• Last Update Submitted: 2010-12-08
• Last Update Posted: 2010-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

• Provision of signed informed consent
• Clinically normal physical findings, laboratory values, vital signs and resting ECG as judged by the investigator

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AZD0328	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Research Site; 🇸🇪 Uppsala, Sweden