Back to resultsA Multiple Dose Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ABT-288 in Stable Subjects With Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
ABT-288
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- Subject has signed informed consent;
- Current DSM-IV-TR diagnosis of schizophrenia;
- Clinically stable on the same single second-generation antipsychotic for the past 8 weeks;
- Meets study-specific PANSS criteria;
- Willing and able to cooperate with cognitive testing
- 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:
- Subject has a substance dependence disorder that has not been in sustained remission for at least 1 year;
- Diagnosis of schizoaffective disorder;
- Bipolar disorder, manic episode, dementia, OCD, or drug-induced psychosis or current major depressive disorder;
- Diagnoses with mental retardation; acute psychosis hospitalization within past 6 months;
- Current clozapine treatment; suicidal ideation or behavior;
- BMI of 39 or greater; current homicidal or violent ideation;
- Medical or CNS condition other than schizophrenia that could affect cognitive performance or testing; relevant drug sensitivity or allergy; positive urine screen for alcohol or drugs of abuse;
- Positive hepatitis or HIV test result;
- Recent clinically significant illness/infection or surgery;
- Recent blood product transfusion, donation or loss of 5 mL/kg of blood;
- Visual, hearing or communication disability
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
1
2
3
4
5
6
7
8
9
Arm Description
ABT-288 vs placebo capsules administered orally once daily for 14 days
ABT-288 vs placebo capsules administered orally once daily for 14 days
ABT-288 vs placebo capsules administered orally once daily for 14 days
ABT288 vs placebo administered orally once daily for 14 days
ABT-288 vs placebo administered orally once daily for 14 days
ABT-288 vs placebo administered orally once daily for 14 days
ABT-288 vs placebo administered orally once daily for 14 days
ABT-288 vs placebo administered orally once daily for 14 days
ABT-288 vs placebo administered orally once daily for 14 days
Outcomes
Primary Outcome Measures
Physical Exams, Brief Neurological Exams, Vitals, Orthostatic Vitals, ECG, Laboratory tests,
Pharmacokinetics; optional CSF for arms 7, 8 & 9
Secondary Outcome Measures
Extrapyramidal Symptom Rating Scale
Columbia Suicide Severity Rating Scale
Pharmacodynamics: CANTAB & PANSS
Pharmacodynamics: Pittsburgh Sleep Quality Index-Modified
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00888693
Brief Title
A Multiple Dose Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ABT-288 in Stable Subjects With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
AbbVie
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluate the safety, tolerability and pharmacokinetics of ABT-288 in order to determine the maximum tolerated dose of ABT-288 in stable schizophrenic volunteers receiving treatment with an atypical antipsychotic.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
ABT-288 vs placebo capsules administered orally once daily for 14 days
Arm Title
2
Arm Type
Experimental
Arm Description
ABT-288 vs placebo capsules administered orally once daily for 14 days
Arm Title
3
Arm Type
Experimental
Arm Description
ABT-288 vs placebo capsules administered orally once daily for 14 days
Arm Title
4
Arm Type
Experimental
Arm Description
ABT288 vs placebo administered orally once daily for 14 days
Arm Title
5
Arm Type
Experimental
Arm Description
ABT-288 vs placebo administered orally once daily for 14 days
Arm Title
6
Arm Type
Experimental
Arm Description
ABT-288 vs placebo administered orally once daily for 14 days
Arm Title
7
Arm Type
Experimental
Arm Description
ABT-288 vs placebo administered orally once daily for 14 days
Arm Title
8
Arm Type
Experimental
Arm Description
ABT-288 vs placebo administered orally once daily for 14 days
Arm Title
9
Arm Type
Experimental
Arm Description
ABT-288 vs placebo administered orally once daily for 14 days
Intervention Type
Drug
Intervention Name(s)
ABT-288
Intervention Description
See Arm Description for details.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
See Arm Description for details.
Primary Outcome Measure Information:
Title
Physical Exams, Brief Neurological Exams, Vitals, Orthostatic Vitals, ECG, Laboratory tests,
Time Frame
Days -1 to 21
Title
Pharmacokinetics; optional CSF for arms 7, 8 & 9
Time Frame
Days -1 to 21
Secondary Outcome Measure Information:
Title
Extrapyramidal Symptom Rating Scale
Time Frame
Day -1, Day 14
Title
Columbia Suicide Severity Rating Scale
Time Frame
Screening, Day 15
Title
Pharmacodynamics: CANTAB & PANSS
Time Frame
Screening, Day -1, Day 14
Title
Pharmacodynamics: Pittsburgh Sleep Quality Index-Modified
Time Frame
Day -1, Day 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject has signed informed consent;
Current DSM-IV-TR diagnosis of schizophrenia;
Clinically stable on the same single second-generation antipsychotic for the past 8 weeks;
Meets study-specific PANSS criteria;
Willing and able to cooperate with cognitive testing
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:
Subject has a substance dependence disorder that has not been in sustained remission for at least 1 year;
Diagnosis of schizoaffective disorder;
Bipolar disorder, manic episode, dementia, OCD, or drug-induced psychosis or current major depressive disorder;
Diagnoses with mental retardation; acute psychosis hospitalization within past 6 months;
Current clozapine treatment; suicidal ideation or behavior;
BMI of 39 or greater; current homicidal or violent ideation;
Medical or CNS condition other than schizophrenia that could affect cognitive performance or testing; relevant drug sensitivity or allergy; positive urine screen for alcohol or drugs of abuse;
Positive hepatitis or HIV test result;
Recent clinically significant illness/infection or surgery;
Recent blood product transfusion, donation or loss of 5 mL/kg of blood;
Visual, hearing or communication disability
12. IPD Sharing Statement
Citations:
PubMed Identifier
24215171
Citation
Othman AA, Haig G, Florian H, Locke C, Gertsik L, Dutta S. The H3 antagonist ABT-288 is tolerated at significantly higher exposures in subjects with schizophrenia than in healthy volunteers. Br J Clin Pharmacol. 2014 Jun;77(6):965-74. doi: 10.1111/bcp.12281.
Results Reference
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A Multiple Dose Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ABT-288 in Stable Subjects With Schizophrenia
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