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Pharmacokinetic Study of ABT-126 in Stable Subjects With Schizophrenia

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ClinicalTrials.gov Identifier: NCT01043458
Recruitment Status : Completed
First Posted : January 6, 2010
Last Update Posted : November 2, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: ABT-126 Drug: Placebo for ABT-126 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of ABT-126 in Stable Subjects With Schizophrenia
Study Start Date : November 2009
Primary Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Adverse Events [ Time Frame: Duration of study ]
  2. ABT-126 levels in blood (plasma) [ Time Frame: Pre-dose to 144 hours post-dose ]
  3. Clinical laboratory tests, vital signs and electrocardiogram (ECG) [ Time Frame: Pre-dose to 72 hours post-dose ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01043458


Locations
United States, California
Site Reference ID/Investigator# 25423
Glendale, California, United States, 91206
United States, Texas
Site Reference ID/Investigator# 24322
San Antonio, Texas, United States, 78217
Sponsors and Collaborators
Abbott
More Information

Responsible Party: Hana Florian, MD / Associate Medical Director, Abbott
ClinicalTrials.gov Identifier: NCT01043458     History of Changes
Other Study ID Numbers: M11-108
First Posted: January 6, 2010    Key Record Dates
Last Update Posted: November 2, 2010
Last Verified: September 2010

Keywords provided by Abbott:
Pharmacokinetics

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders