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OpenTrials
Completed

NCT Number: NCT00687141

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

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Linköping, Sweden

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD0328

Drug

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

Drug

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

Primary outcomes

  1. 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.

  2. 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

  1. Determine the single and multiple dose pharmacokinetics (PK) of AZD0328

    Time frame: PK sampling taken at defined timepoints during residential period.

  2. Evaluate the cognitive dose response relationship for AZD0328

    Time frame: Psychometric test battery performed at defined timepoints during residential period.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 30, 2008
Registry last updated
Dec 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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