Schizophrenia or Schizoaffective
Conditions
Brief summary
Study ITI-007-037 is a Phase 1b, open-label study to evaluate the safety, tolerability, and PK of lumateperone long-acting injectable (LAI) formulations after a single intramuscular injection in patients with stale schizophrenia or schizoaffective disorder.
Interventions
DRUGLumateperone Capsule
Lumateperone 42 mg capsule, oral administration
DRUGLumateperone LAI
Lumateperone LAI X500-E2 IM injection
Sponsors
Intra-Cellular Therapies, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study includes 3 sequential study parts (Parts A, B and C). Part A consists of 4 cohorts (Cohorts 1 to 4), Part B of up to 3 cohorts (Cohorts 5 to 7), and Part C of up to 2 cohorts (Cohorts 8 and 9). Within each study part, cohorts may be enrolled in parallel.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Male or female patients between 18 and 55 years of age, inclusive; * Clinical diagnosis of schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5); * Clinically stable and free from acute exacerbation of psychosis for at least 3 months prior to Screening; * Clinical Global Impression - Severity (CGI-S) score ≤ 3 at Screening and prior to dosing on Day 1; * Body mass index (BMI) between 18.0 and 38.0 kg/m2, inclusive at Screening, and a minimum body weight of 50 kg at Screening. Main
Exclusion criteria
* History of psychiatric condition other than schizophrenia that, in the Investigator's opinion, may be detrimental to participation in the study; * Any suicidal ideation or wish to be dead within the past 6 months of Screening, any suicide attempt within the past 2 years prior to Screening, or any current concern for the patient's safety based on the Columbia-Suicide Severity Rating Scale (C-SSRS) (excluding self-injurious, non-suicidal behavior), and/or Investigator assessment that the patient is a safety risk to him/herself or others; * Clinically significant abnormality within 2 years of Screening that in the Investigator's opinion may place the patient at risk or interfere with study outcome variables; * Has a QT interval corrected for heart rate using Fridericia formula \> 450 msec in males or \> 470 msec in females, or evidence of clinically significant bundle branch blocks on ECG at Screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics: Cmax,oral | Day 5 | Maximum plasma concentration of lumateperone |
| Pharmacokinetics: Cmax,IM | Day 11-60 | Maximum plasma concentration of lumateperone |
| Pharmacokinetics: Tmax,oral | Day 5 | Time of maximum concentration of lumateperone in plasma |
| Pharmacokinetics: Tmax,IM | Day 11-60 | Time of maximum concentration of lumateperone in plasma |
| Pharmacokinetics: AUC0-t,oral | Day 5 | Area under the plasma concentration time curve from time zero to the last measurable of concentration of lumateperone |
| Pharmacokinetics: AUC0-t,IM | Day 11-60 | Area under the plasma concentration time curve from time zero to the last measurable of concentration of lumateperone |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects with treatment-emergent adverse events | up to 30 days after the last protocol-defined study visit | — |
| Change from baseline in systolic and diastolic blood pressure | Days 25 and 60 | — |
| Change from baseline in ECG QTcF interval | Days 25 and 60 | — |
| Change from baseline in hemoglobin | Days 25 and 60 | — |
| Change from baseline in white blood cell count | Days 25 and 60 | — |
| Change from baseline in aspartate aminotransferase | Days 25 and 60 | — |
| Change from baseline in alanine aminotransferase | Days 25 and 60 | — |
| Change from baseline in Abnormal Involuntary Movement Scale (AIMS) | Days 25 and 60 | AIMS is a measure of facial and oral movements, extremity movements and trunk movements. Items are rated on a scale from none (0) to severe (4). |
Countries
United States
Contacts
STUDY_DIRECTORIntra-Cellular Therapies, Inc. Clinical Trial
Intra-Cellular Therapies, Inc.
Outcome results
None listed