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

December 8, 2010 updated by: AstraZeneca

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Linkoping, Sweden
        • Research Site
      • Lulea, Sweden
        • Research Site
      • Stockholm, Sweden
        • Research Site
      • Uppsala, Sweden
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 2
Drug: Placebo
Administered orally as a solution once per day on day 1, and then day 3 through to day 14.
EXPERIMENTAL: 1
Drug: AZD0328
Oral solution administered orally once per day on day 1, and then day 3 through to day 14. Specific dose depends on dose panel.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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.
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

Outcome Measure
Time Frame
Determine the single and multiple dose pharmacokinetics (PK) of AZD0328
Time Frame: PK sampling taken at defined timepoints during residential period.
PK sampling taken at defined timepoints during residential period.
Evaluate the cognitive dose response relationship for AZD0328
Time Frame: Psychometric test battery performed at defined timepoints during residential period.
Psychometric test battery performed at defined timepoints during residential period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Wolfgang Kühn, Quintiles ABStrandbodgatan 1S-753 23 Uppsala
  • Study Chair: Erik Eliasson, MD, PhD, AstraZeneca R&D SödertäljeMedical Science S-151 85 Södertälje Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (ACTUAL)

June 1, 2008

Study Completion (ACTUAL)

June 1, 2008

Study Registration Dates

First Submitted

May 28, 2008

First Submitted That Met QC Criteria

May 29, 2008

First Posted (ESTIMATE)

May 30, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 10, 2010

Last Update Submitted That Met QC Criteria

December 8, 2010

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D0190C00006
  • EudractCT 2007-004598-25

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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