CompletedNCT00633048Updated Feb 17, 2009

Study Evaluating the Safety and Tolerability of NSA-789

A Phase 1 interventional study of NSA-789 and placebo in Healthy, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-02-17.

Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer · Phase 1 and Interventional

Phase: Phase 1
Study type: Interventional
Enrollment: 64
Allocation: Randomized
Ages: 18 Years to 50 Years
Sex: All

Study 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.

Conditions studied

Healthy

Keywords

ascending single-dose study
healthy subjects

In context

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer is the lead sponsor of 472 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Eligibility 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.

Study design

Phase: Phase 1
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 64 participants (estimated)

Study arms

Experimental
NSA-789
active drug
Drug: NSA-789
Placebo comparator
placebo
placebo
Drug: placebo

Interventions

DrugNSA-789
Drugplacebo

What researchers measure

Primary outcomes

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 outcomes

pharmacokinetics
Time frame: 3 months

Study locations

1 site

Tacoma, Washington 98418, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 17, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00633048
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: Mar 11, 2008
Start date: Mar 2008
Primary completion: May 2008
Completion: May 2008
Last update: Feb 17, 2009

Study contacts

Medical Monitor

study director · Wyeth is now a wholly owned subsidiary of Pfizer

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.

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Discussion

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