Pharmacokinetic Study of ABT-126 in Stable Subjects With Schizophrenia - Full Text View

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:

MedlinePlus related topics: Schizophrenia

U.S. FDA Resources

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

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 May 23, 2013