Study Evaluating the Safety and Tolerability of NSA-789

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00633048
First received: February 8, 2008
Last updated: February 16, 2009
Last verified: February 2009
  Purpose

This is the first time that NSA-789, a new compound being developed for schizophrenia, will be given to humans. Each healthy subject will receive a single dose, except for 8 subjects who will receive 2 doses-- one dose under fasting conditions and one dose after eating food.


Condition Intervention Phase
Healthy
Drug: NSA-789
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NSA-789 Administered Orally to Healthy Subjects

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Safety and tolerability from reported adverse events, scheduled physical examinations, vital signs, cardiac rhythm monitoring, 12-lead ECGs, and clinical laboratory test results [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • pharmacokinetics [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: March 2008
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NSA-789
active drug
Drug: NSA-789
Placebo Comparator: placebo
placebo
Drug: placebo

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion:

  • Healthy men and women between 18 and 50 years old.
  • Women must be of non-child-bearing potential (not able to have children).
  • Must be of normal body weight.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00633048

Locations
United States, Washington
Tacoma, Washington, United States, 98418
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trials Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00633048     History of Changes
Other Study ID Numbers: 3230A1-1000
Study First Received: February 8, 2008
Last Updated: February 16, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
ascending single-dose study
healthy subjects

ClinicalTrials.gov processed this record on April 16, 2014