Pharmacokinetic Study of ABT-126 in Stable Subjects With Schizophrenia

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01043458

Enrollment

Registered

2010-01-06

Start date

2009-11-30

Completion date

Unknown

Last updated

2010-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Pharmacokinetics

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.

Interventions

DRUGABT-126

ABT-126 Low Dose & ABT-126 High Dose

DRUGPlacebo for ABT-126

Matching Placebo for Arms 1 & 2

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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;

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026