Back to resultsPharmacokinetic Study of ABT-126 in Stable Subjects With Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ABT-126
Placebo for ABT-126
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Pharmacokinetics
Eligibility 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;
Sites / Locations
- Site Reference ID/Investigator# 25423
- Site Reference ID/Investigator# 24322
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
1
2
3
Arm Description
ABT-126 Low Dose
ABT-126 High Dose
Placebo for ABT-126
Outcomes
Primary Outcome Measures
Adverse Events
ABT-126 levels in blood (plasma)
Clinical laboratory tests, vital signs and electrocardiogram (ECG)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01043458
Brief Title
Pharmacokinetic Study of ABT-126 in Stable Subjects With Schizophrenia
Official Title
A Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of ABT-126 in Stable Subjects With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Pharmacokinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
ABT-126 Low Dose
Arm Title
2
Arm Type
Experimental
Arm Description
ABT-126 High Dose
Arm Title
3
Arm Type
Experimental
Arm Description
Placebo for ABT-126
Intervention Type
Drug
Intervention Name(s)
ABT-126
Intervention Description
ABT-126 Low Dose & ABT-126 High Dose
Intervention Type
Drug
Intervention Name(s)
Placebo for ABT-126
Intervention Description
Matching Placebo for Arms 1 & 2
Primary Outcome Measure Information:
Title
Adverse Events
Time Frame
Duration of study
Title
ABT-126 levels in blood (plasma)
Time Frame
Pre-dose to 144 hours post-dose
Title
Clinical laboratory tests, vital signs and electrocardiogram (ECG)
Time Frame
Pre-dose to 72 hours post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Facility Information:
Facility Name
Site Reference ID/Investigator# 25423
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Site Reference ID/Investigator# 24322
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetic Study of ABT-126 in Stable Subjects With Schizophrenia
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