Pharmacokinetic Study of ABT-126 in Stable Subjects With Schizophrenia

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01043458
• Other study ID #: M11-108
• Status: Completed
• Phase: Phase 1
• First received: October 21, 2009
• Last updated: November 1, 2010
• Start date: November 2009

Study information

• Verified date: September 2010
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• 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;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• ABT-126
ABT-126 Low Dose & ABT-126 High Dose
• Placebo for ABT-126
Matching Placebo for Arms 1 & 2

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 25423	Glendale	California
United States	Site Reference ID/Investigator# 24322	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

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