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

NCT00687141 | Completed Phase 1 DMC

• 2 other identifiers: D0190C00006EudractCT 2007-004598-25
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 4

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.

Conditions

Alzheimer's Disease

Keywords

Safety; tolerability; AZD0328

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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.

Study Arms (2)

1

EXPERIMENTAL

Drug: AZD0328

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

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.

1

Placebo DRUG

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

2

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (4)

Research Site

Linköping, Sweden

Location

Research Site

Luleå, Sweden

Location

Research Site

Stockholm, Sweden

Location

Research Site

Uppsala, Sweden

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

spiro(1-azabicyclo(2.2.2)octane-3,2'(3H)-furo(2,3-b)pyridine)

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Wolfgang Kühn

  Quintiles ABStrandbodgatan 1S-753 23 Uppsala

  PRINCIPAL INVESTIGATOR

• Erik Eliasson, MD, PhD

  AstraZeneca R&D SödertäljeMedical Science S-151 85 Södertälje Sweden

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 28, 2008
• First Posted: May 30, 2008
• Study Start: November 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: December 10, 2010

Record last verified: 2008-07

Locations

SE (4)