Skip to main content
OpenTrials
Completed

NCT Number: NCT01043458

Pharmacokinetic Study of ABT-126 in Stable Subjects With Schizophrenia

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site Reference ID/Investigator# 25423, Glendale, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

ABT-126

Drug

ABT-126 Low Dose & ABT-126 High Dose

Placebo for ABT-126

Drug

Matching Placebo for Arms 1 & 2

Primary outcomes

  1. Adverse Events

    Time frame: Duration of study

  2. ABT-126 levels in blood (plasma)

    Time frame: Pre-dose to 144 hours post-dose

  3. Clinical laboratory tests, vital signs and electrocardiogram (ECG)

    Time frame: Pre-dose to 72 hours post-dose

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
First posted
Jan 6, 2010
Registry last updated
Nov 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.