Pharmacokinetic Study of ABT-126 in Stable Subjects With Schizophrenia

November 1, 2010 updated by: Abbott

A Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of ABT-126 in Stable Subjects With Schizophrenia

A study to investigate the process by which ABT-126 is absorbed, distributed, metabolized and eliminated by the body of stable schizophrenic volunteers receiving treatment with an atypical antipsychotic.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Glendale, California, United States, 91206
        • Site Reference ID/Investigator# 25423
    • Texas
      • San Antonio, Texas, United States, 78217
        • Site Reference ID/Investigator# 24322

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject has signed informed consent;
  • Current diagnosis of schizophrenia;
  • Clinically stable on the same single second-generation (atypical) antipsychotic for the past 8 weeks;
  • Meets study-specific criteria for Positive and Negative Syndrome Scale (PANSS);
  • Females are not pregnant, not breast-feeding;
  • Females are post-menopausal or surgically sterile or practicing birth control;
  • Males are surgically sterile or agree to be sexually inactive or use barrier method of birth control

Exclusion Criteria:

  • Diagnosis of schizoaffective disorder;
  • Diagnosis with mental retardation;
  • Subject has a substance dependence disorder that has not been in sustained remission for at least 1 year;
  • Acute psychosis hospitalization within past 6 months;
  • Bipolar disorder, manic episode, dementia, obsessive-compulsive disorder, or drug-induced psychosis or current major depressive disorder;
  • Current clozapine treatment;
  • Suicidal ideation or behavior;
  • BMI of 39 or greater;
  • Relevant drug sensitivity or allergy;
  • Positive hepatitis or HIV test result; positive urine screen for drugs of abuse or alcohol;
  • Recent clinically significant illness/infection or surgery;
  • Recent blood product transfusion, donation or loss of 5 mL/kg of blood;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
ABT-126 Low Dose
Drug: ABT-126
ABT-126 Low Dose & ABT-126 High Dose
Experimental: 2
ABT-126 High Dose
Drug: ABT-126
ABT-126 Low Dose & ABT-126 High Dose
Experimental: 3
Placebo for ABT-126
Drug: Placebo for ABT-126
Matching Placebo for Arms 1 & 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse Events
Time Frame: Duration of study
Duration of study
ABT-126 levels in blood (plasma)
Time Frame: Pre-dose to 144 hours post-dose
Pre-dose to 144 hours post-dose
Clinical laboratory tests, vital signs and electrocardiogram (ECG)
Time Frame: Pre-dose to 72 hours post-dose
Pre-dose to 72 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

October 21, 2009

First Submitted That Met QC Criteria

January 5, 2010

First Posted (Estimate)

January 6, 2010

Study Record Updates

Last Update Posted (Estimate)

November 2, 2010

Last Update Submitted That Met QC Criteria

November 1, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M11-108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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