Study Evaluating the Safety and Tolerability of NSA-789

Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NSA-789 Administered Orally to Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00633048

Enrollment

Registered

2008-03-11

Start date

2008-03-31

Completion date

2008-05-31

Last updated

2009-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

ascending single-dose study, healthy subjects

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.

Interventions

DRUGNSA-789

DRUGplacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion 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.

Design outcomes

Primary

Measure	Time frame
Safety and tolerability from reported adverse events, scheduled physical examinations, vital signs, cardiac rhythm monitoring, 12-lead ECGs, and clinical laboratory test results	3 months

Secondary

Measure	Time frame
pharmacokinetics	3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026