Pharmacokinetic Study of ABT-126 in Stable Subjects With Schizophrenia
- Registration Number
- NCT01043458
- Lead Sponsor
- Abbott
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 ABT-126 ABT-126 High Dose 3 Placebo for ABT-126 Placebo for ABT-126 1 ABT-126 ABT-126 Low Dose
- Primary Outcome Measures
Name Time Method Adverse Events Duration of study ABT-126 levels in blood (plasma) Pre-dose to 144 hours post-dose Clinical laboratory tests, vital signs and electrocardiogram (ECG) Pre-dose to 72 hours post-dose
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Site Reference ID/Investigator# 25423
🇺🇸Glendale, California, United States
Site Reference ID/Investigator# 24322
🇺🇸San Antonio, Texas, United States