NCT00633048

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Mar 2008

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2008

Completed
22 days until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 11, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

February 17, 2009

Status Verified

February 1, 2009

Enrollment Period

2 months

First QC Date

February 8, 2008

Last Update Submit

February 16, 2009

Conditions

Healthy

Keywords

ascending single-dose studyhealthy subjects

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • pharmacokinetics

    3 months

Study Arms (2)

NSA-789

EXPERIMENTAL

active drug

Drug: NSA-789

placebo

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

NSA-789DRUG
NSA-789
placeboDRUG
placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tacoma, Washington, 98418, United States

Location

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 8, 2008

First Posted

March 11, 2008

Study Start

March 1, 2008

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

February 17, 2009

Record last verified: 2009-02

Locations

US(1)