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Pharmacokinetic Study of ABT-126 in Stable Subjects With Schizophrenia

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Abbott

Status and phase

Completed
Phase 1

Conditions

Schizophrenia

Treatments

Drug: Placebo for ABT-126
Drug: ABT-126

Study type

Interventional

Funder types

Industry

Identifiers

NCT01043458
M11-108

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No 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;

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

16 participants in 3 patient groups

1
Experimental group
Description:
ABT-126 Low Dose
Treatment:
Drug: ABT-126
2
Experimental group
Description:
ABT-126 High Dose
Treatment:
Drug: ABT-126
3
Experimental group
Description:
Placebo for ABT-126
Treatment:
Drug: Placebo for ABT-126

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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