Schizophrenia Clinical Trial
Official title:
A Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of ABT-126 in Stable Subjects With Schizophrenia
NCT number | NCT01043458 |
Other study ID # | M11-108 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | October 21, 2009 |
Last updated | November 1, 2010 |
Start date | November 2009 |
Verified date | September 2010 |
Source | Abbott |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
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; |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Site Reference ID/Investigator# 25423 | Glendale | California |
United States | Site Reference ID/Investigator# 24322 | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Abbott |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse Events | Duration of study | Yes | |
Primary | ABT-126 levels in blood (plasma) | Pre-dose to 144 hours post-dose | No | |
Primary | Clinical laboratory tests, vital signs and electrocardiogram (ECG) | Pre-dose to 72 hours post-dose | Yes |
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