Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizophrenia or Schizoaffective Disorder
Phase 1
Recruiting
- Conditions
- Schizophrenia or Schizoaffective
- Interventions
- Registration Number
- NCT06627413
- Lead Sponsor
- Intra-Cellular Therapies, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 72
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 2 Lumateperone Capsule Lumateperone 42 mg once daily for 5 days following by a single IM dose of lumateperone 100 mg LAI formulation X500-E3 after a 5-day washout Cohort 3 Lumateperone Capsule Lumateperone 42 mg once daily for 5 days following by a single IM dose of lumateperone 100 mg LAI formulation X500-X2 after a 5-day washout Cohort 4 Lumateperone LAI Lumateperone 42 mg once daily for 5 days following by a single IM dose of lumateperone 100 mg LAI formulation X500-X5 after a 5-day washout Cohort 8 Lumateperone LAI Lumateperone 42 mg once daily for 5 days following by a single IM dose (\> dose in Part B) of lumateperone LAI formulation (chosen from Part B) after a 5-day washout Cohort 9 Lumateperone LAI Lumateperone 42 mg once daily for 5 days following by a single IM dose (\> dose in Part B) of lumateperone LAI formulation (chosen from Part B) after a 5-day washout Cohort 1 Lumateperone Capsule Lumateperone 42 mg once daily for 5 days following by a single IM dose of lumateperone 100 mg LAI formulation X500-E2 after a 5-day washout Cohort 5 Lumateperone LAI Lumateperone 42 mg once daily for 5 days following by a single IM dose (\> 100 mg) of lumateperone LAI formulation (chosen from Part A) after a 5-day washout Cohort 6 Lumateperone Capsule Lumateperone 42 mg once daily for 5 days following by a single IM dose (\> 100 mg) of lumateperone LAI formulation (chosen from Part A) after a 5-day washout Cohort 6 Lumateperone LAI Lumateperone 42 mg once daily for 5 days following by a single IM dose (\> 100 mg) of lumateperone LAI formulation (chosen from Part A) after a 5-day washout Cohort 8 Lumateperone Capsule Lumateperone 42 mg once daily for 5 days following by a single IM dose (\> dose in Part B) of lumateperone LAI formulation (chosen from Part B) after a 5-day washout Cohort 1 Lumateperone LAI Lumateperone 42 mg once daily for 5 days following by a single IM dose of lumateperone 100 mg LAI formulation X500-E2 after a 5-day washout Cohort 3 Lumateperone LAI Lumateperone 42 mg once daily for 5 days following by a single IM dose of lumateperone 100 mg LAI formulation X500-X2 after a 5-day washout Cohort 4 Lumateperone Capsule Lumateperone 42 mg once daily for 5 days following by a single IM dose of lumateperone 100 mg LAI formulation X500-X5 after a 5-day washout Cohort 9 Lumateperone Capsule Lumateperone 42 mg once daily for 5 days following by a single IM dose (\> dose in Part B) of lumateperone LAI formulation (chosen from Part B) after a 5-day washout Cohort 2 Lumateperone LAI Lumateperone 42 mg once daily for 5 days following by a single IM dose of lumateperone 100 mg LAI formulation X500-E3 after a 5-day washout Cohort 5 Lumateperone Capsule Lumateperone 42 mg once daily for 5 days following by a single IM dose (\> 100 mg) of lumateperone LAI formulation (chosen from Part A) after a 5-day washout Cohort 7 Lumateperone Capsule Lumateperone 42 mg once daily for 5 days following by a single IM dose (\> 100 mg) of lumateperone LAI formulation (chosen from Part A) after a 5-day washout Cohort 7 Lumateperone LAI Lumateperone 42 mg once daily for 5 days following by a single IM dose (\> 100 mg) of lumateperone LAI formulation (chosen from Part A) after a 5-day washout
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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).
Trial Locations
- Locations (4)
Clinical Site 2
🇺🇸Los Alamitos, California, United States
Clinical Site 3
🇺🇸Atlanta, Georgia, United States
Clinical Site 4
🇺🇸Decatur, Georgia, United States
Clinical Site 1
🇺🇸Marlton, New Jersey, United States