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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 30, 2014