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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Alzheimer's Disease

Treatments: Drug: Placebo; Drug: AZD0328

Study type: Interventional

Funder types: Industry

Identifiers

NCT00687141

D0190C00006

EudractCT 2007-004598-25

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: All

Ages: 60 to 80 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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112 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: AZD0328

2

Placebo Comparator group

Treatment:

Drug: Placebo