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Study Evaluating the Safety and Tolerability of NSA-789

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ClinicalTrials.gov Identifier: NCT00633048
Recruitment Status : Completed
First Posted : March 11, 2008
Last Update Posted : February 17, 2009
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: NSA-789 Drug: placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NSA-789 Administered Orally to Healthy Subjects
Study Start Date : March 2008
Primary Completion Date : May 2008
Study Completion Date : May 2008
Arms and Interventions

Arm Intervention/treatment
Experimental: NSA-789
active drug
Drug: NSA-789
Placebo Comparator: placebo
Drug: placebo

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. pharmacokinetics [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00633048

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

Responsible Party: Wyeth (Registry Contact: Clinical Trials Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00633048     History of Changes
Other Study ID Numbers: 3230A1-1000
First Posted: March 11, 2008    Key Record Dates
Last Update Posted: February 17, 2009
Last Verified: February 2009

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