NCT00687141CompletedPhase 1
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- Safety and tolerability of AZD0328 by assessment of vital signs, laboratory variables and ECG
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to 80 Years (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
1
Experimental
Intervention: AZD0328 (Drug)
2
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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.
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 Outcomes
- 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.)
Investigators
Study Sites (1)
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