NCT00952393

Brief Summary

The study determines if a new preparation of a drug designed to treat schizophrenia is more slowly released into the body.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1 schizophrenia

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_1 schizophrenia

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

August 3, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 6, 2009

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

February 5, 2016

Completed
Last Updated

February 5, 2016

Status Verified

January 1, 2016

Enrollment Period

4.8 years

First QC Date

August 3, 2009

Results QC Date

November 25, 2015

Last Update Submit

January 6, 2016

Conditions

Schizophrenia

Keywords

receptors nicotinic

Outcome Measures

Primary Outcomes (1)

  • Blood Levels of Drug

    This is the plasma level of the drug as determined by high performance liquid chromatography.

    12 hours

Study Arms (1)

Pharmacokinetic

OTHER

This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation.

Drug: Pharmacokinetic

Interventions

PharmacokineticDRUG

Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined

Also known as: GTS-21
Pharmacokinetic

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers: males and females who are incapable of pregnancy

You may not qualify if:

  • Medical illnesses requiring acute treatment
  • History of seizures
  • Substance abuse including nicotine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Eastern Colorado Health Care System, Denver

Denver, Colorado, 80220, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Pharmacogenomic Variants3-(2,4-dimethoxybenzylidene)anabaseine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Polymorphism, GeneticGenetic VariationGenetic Phenomena

Results Point of Contact

Title
Dr. Robert Freedman
Organization
University of Colorado
Robert.Freedman@ucdenver.edu
3037244940

Study Officials

  • Robert Freedman, MD

    VA Eastern Colorado Health Care System, Denver

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2009

First Posted

August 6, 2009

Study Start

January 1, 2010

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

February 5, 2016

Results First Posted

February 5, 2016

Record last verified: 2016-01

Locations

US(1)