Pharmacokinetic Study of ABT-126 in Stable Subjects With Schizophrenia

Study Overview
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Brief Summary
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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.

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

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: ABT-126
* Drug: Placebo for ABT-126


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics