Pharmacokinetic Study of ABT-126 in Stable Subjects With Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT01043458
First received: October 21, 2009
Last updated: November 1, 2010
Last verified: September 2010
  Purpose

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 Intervention Phase
Schizophrenia
Drug: ABT-126
Drug: Placebo for ABT-126
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of ABT-126 in Stable Subjects With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
  • ABT-126 levels in blood (plasma) [ Time Frame: Pre-dose to 144 hours post-dose ] [ Designated as safety issue: No ]
  • Clinical laboratory tests, vital signs and electrocardiogram (ECG) [ Time Frame: Pre-dose to 72 hours post-dose ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: November 2009
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ABT-126 Low Dose
Drug: ABT-126
ABT-126 Low Dose & ABT-126 High Dose
Other Name: ABT-126
Experimental: 2
ABT-126 High Dose
Drug: ABT-126
ABT-126 Low Dose & ABT-126 High Dose
Other Name: ABT-126
Experimental: 3
Placebo for ABT-126
Drug: Placebo for ABT-126
Matching Placebo for Arms 1 & 2
Other Name: Placebo for ABT-126

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hana Florian, MD / Associate Medical Director, Abbott
ClinicalTrials.gov Identifier: NCT01043458     History of Changes
Other Study ID Numbers: M11-108
Study First Received: October 21, 2009
Last Updated: November 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Pharmacokinetics

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014