Multiple Dose Study Evaluating the Safety and Tolerability of NSA-789

August 17, 2021 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

An Ascending Multiple Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of NSA-789 Administered Orally to Healthy Subjects and Subjects With Alzheimer's Disease

This is a multiple dose study of NSA-789, the purpose of which is to assess the safety and tolerability in healthy subjects and subjects with Alzheimer's Disease

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

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

  • United States
    • California
      • Glendale, California, United States, 91206

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

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Men or women aged 18 - 50 years (healthy subjects) or greater than 55 years old (subjects with Alzheimer's Disease)
  • Women must be surgically sterile or postmenopausal
  • Subjects with Alzheimer's Disease must be generally healthy, but may have a stable, chronic illness if well controlled.

Exclusion Criteria

  • Healthy subjects may not be on any prescription or investigation drugs within 30 days of start of study.
  • Subjects with Alzheimer's Disease may not be on any cholinesterase inhibitors such as donepezil (Aricept®) or rivastigmine (Exelon®) within 4 weeks of the start of the study.

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: placebo
Other: placebo
EXPERIMENTAL: NSA-789
Drug: NSA-789

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse event monitoring as specific tests that will be done to monitor safety (ECGs, certain laboratory tests, vital signs) and tolerability
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic and pharmcodynamic parameters
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

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 (ACTUAL)

January 1, 2009

Primary Completion (ACTUAL)

May 1, 2009

Study Completion (ACTUAL)

May 1, 2009

Study Registration Dates

First Submitted

November 20, 2008

First Submitted That Met QC Criteria

November 20, 2008

First Posted (ESTIMATE)

November 21, 2008

Study Record Updates

Last Update Posted (ACTUAL)

August 20, 2021

Last Update Submitted That Met QC Criteria

August 17, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3230A1-1002

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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