Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizophrenia or Schizoaffective Disorder
July 30, 2026 updated by: Intra-Cellular Therapies, Inc.
A Phase 1b, Open-label Study to Determine the Pharmacokinetics, Safety, and Tolerability of Single, Ascending Doses of Lumateperone Long-acting Injectable Formulations Administered Intramuscularly to Patients With Schizophrenia or Schizoaffective Disorder
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Alamitos, California, United States, 90720
- Collaborative Neuroscience Research, LLC
-
-
Georgia
-
Atlanta, Georgia, United States, 30331
- Atlanta Center for Medical Research
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Atlanta, Georgia, United States, 30030
- CenExeli Research LLC
-
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New Jersey
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Marlton, New Jersey, United States, 08053
- Hassman Research Institute, LLC.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cohort 1
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
|
Lumateperone 42 mg capsule, oral administration
Lumateperone LAI X500-E2 IM injection
Lumateperone LAI X500-E3 IM injection
Lumateperone LAI X500-X2 IM injection
Lumateperone LAI X500-X5 IM injection
Lumateperone LAI (X500-E2 or X500-E3 or X500-X2 or X500-X5) IM injection
|
|
Experimental: Cohort 2
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
|
Lumateperone 42 mg capsule, oral administration
Lumateperone LAI X500-E2 IM injection
Lumateperone LAI X500-E3 IM injection
Lumateperone LAI X500-X2 IM injection
Lumateperone LAI X500-X5 IM injection
Lumateperone LAI (X500-E2 or X500-E3 or X500-X2 or X500-X5) IM injection
|
|
Experimental: Cohort 3
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
|
Lumateperone 42 mg capsule, oral administration
Lumateperone LAI X500-E2 IM injection
Lumateperone LAI X500-E3 IM injection
Lumateperone LAI X500-X2 IM injection
Lumateperone LAI X500-X5 IM injection
Lumateperone LAI (X500-E2 or X500-E3 or X500-X2 or X500-X5) IM injection
|
|
Experimental: Cohort 4
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
|
Lumateperone 42 mg capsule, oral administration
Lumateperone LAI X500-E2 IM injection
Lumateperone LAI X500-E3 IM injection
Lumateperone LAI X500-X2 IM injection
Lumateperone LAI X500-X5 IM injection
Lumateperone LAI (X500-E2 or X500-E3 or X500-X2 or X500-X5) IM injection
|
|
Experimental: Cohort 5
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
|
Lumateperone 42 mg capsule, oral administration
Lumateperone LAI X500-E2 IM injection
Lumateperone LAI X500-E3 IM injection
Lumateperone LAI X500-X2 IM injection
Lumateperone LAI X500-X5 IM injection
Lumateperone LAI (X500-E2 or X500-E3 or X500-X2 or X500-X5) IM injection
|
|
Experimental: Cohort 6
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
|
Lumateperone 42 mg capsule, oral administration
Lumateperone LAI X500-E2 IM injection
Lumateperone LAI X500-E3 IM injection
Lumateperone LAI X500-X2 IM injection
Lumateperone LAI X500-X5 IM injection
Lumateperone LAI (X500-E2 or X500-E3 or X500-X2 or X500-X5) IM injection
|
|
Experimental: Cohort 7
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
|
Lumateperone 42 mg capsule, oral administration
Lumateperone LAI X500-E2 IM injection
Lumateperone LAI X500-E3 IM injection
Lumateperone LAI X500-X2 IM injection
Lumateperone LAI X500-X5 IM injection
Lumateperone LAI (X500-E2 or X500-E3 or X500-X2 or X500-X5) IM injection
|
|
Experimental: Cohort 8
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
|
Lumateperone 42 mg capsule, oral administration
Lumateperone LAI X500-E2 IM injection
Lumateperone LAI X500-E3 IM injection
Lumateperone LAI X500-X2 IM injection
Lumateperone LAI X500-X5 IM injection
Lumateperone LAI (X500-E2 or X500-E3 or X500-X2 or X500-X5) IM injection
|
|
Experimental: Cohort 9
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
|
Lumateperone 42 mg capsule, oral administration
Lumateperone LAI X500-E2 IM injection
Lumateperone LAI X500-E3 IM injection
Lumateperone LAI X500-X2 IM injection
Lumateperone LAI X500-X5 IM injection
Lumateperone LAI (X500-E2 or X500-E3 or X500-X2 or X500-X5) IM injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pharmacokinetics: Cmax,oral
Time Frame: Day 5
|
Maximum plasma concentration of lumateperone
|
Day 5
|
|
Pharmacokinetics: Cmax,IM
Time Frame: Day 11-60
|
Maximum plasma concentration of lumateperone
|
Day 11-60
|
|
Pharmacokinetics: Tmax,oral
Time Frame: Day 5
|
Time of maximum concentration of lumateperone in plasma
|
Day 5
|
|
Pharmacokinetics: Tmax,IM
Time Frame: Day 11-60
|
Time of maximum concentration of lumateperone in plasma
|
Day 11-60
|
|
Pharmacokinetics: AUC0-t,oral
Time Frame: Day 5
|
Area under the plasma concentration time curve from time zero to the last measurable of concentration of lumateperone
|
Day 5
|
|
Pharmacokinetics: AUC0-t,IM
Time Frame: Day 11-60
|
Area under the plasma concentration time curve from time zero to the last measurable of concentration of lumateperone
|
Day 11-60
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of subjects with treatment-emergent adverse events
Time Frame: up to 30 days after the last protocol-defined study visit
|
up to 30 days after the last protocol-defined study visit
|
|
|
Change from baseline in systolic and diastolic blood pressure
Time Frame: Days 25 and 60
|
Days 25 and 60
|
|
|
Change from baseline in ECG QTcF interval
Time Frame: Days 25 and 60
|
Days 25 and 60
|
|
|
Change from baseline in hemoglobin
Time Frame: Days 25 and 60
|
Days 25 and 60
|
|
|
Change from baseline in white blood cell count
Time Frame: Days 25 and 60
|
Days 25 and 60
|
|
|
Change from baseline in aspartate aminotransferase
Time Frame: Days 25 and 60
|
Days 25 and 60
|
|
|
Change from baseline in alanine aminotransferase
Time Frame: Days 25 and 60
|
Days 25 and 60
|
|
|
Change from baseline in Abnormal Involuntary Movement Scale (AIMS)
Time Frame: 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).
|
Days 25 and 60
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Intra-Cellular Therapies, Inc. Clinical Trial, Intra-Cellular Therapies, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 23, 2024
Primary Completion (Actual)
November 20, 2025
Study Completion (Actual)
November 20, 2025
Study Registration Dates
First Submitted
October 2, 2024
First Submitted That Met QC Criteria
October 2, 2024
First Posted (Actual)
October 4, 2024
Study Record Updates
Last Update Posted (Actual)
July 31, 2026
Last Update Submitted That Met QC Criteria
July 30, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ITI-007-037 (Other Identifier: Janssen Research & Development, LLC)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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