Pharmacokinetic Study of ABT-126 in Stable Subjects With Schizophrenia

NCT01043458 | Completed Phase 1

• 1 other identifier: M11-108
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

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.

Conditions

Schizophrenia

Keywords

Pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

1

EXPERIMENTAL

ABT-126 Low Dose

Drug: ABT-126

2

EXPERIMENTAL

ABT-126 High Dose

Drug: ABT-126

3

EXPERIMENTAL

Placebo for ABT-126

Drug: Placebo for ABT-126

Interventions

ABT-126 DRUG

ABT-126 Low Dose \& ABT-126 High Dose

1; 2

Placebo for ABT-126 DRUG

Matching Placebo for Arms 1 \& 2

3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Abbott: lead

Study Sites (2)

Site Reference ID/Investigator# 25423

Glendale, California, 91206, United States

Location

Site Reference ID/Investigator# 24322

San Antonio, Texas, 78217, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

ABT-126

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 21, 2009
• First Posted: January 6, 2010
• Study Start: November 1, 2009
• Primary Completion: January 1, 2010
• Last Updated: November 2, 2010

Record last verified: 2010-09

Locations

US (2)