Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizophrenia or Schizoaffective Disorder
NCT ID: NCT06627413
Last Updated: 2025-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
72 participants
INTERVENTIONAL
2024-08-23
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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 Capsule
Lumateperone 42 mg capsule, oral administration
Lumateperone LAI
Lumateperone LAI X500-E2 IM injection
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 Capsule
Lumateperone 42 mg capsule, oral administration
Lumateperone LAI
Lumateperone LAI X500-E3 IM injection
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 Capsule
Lumateperone 42 mg capsule, oral administration
Lumateperone LAI
Lumateperone LAI X500-X2 IM injection
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 Capsule
Lumateperone 42 mg capsule, oral administration
Lumateperone LAI
Lumateperone LAI X500-X5 IM injection
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 Capsule
Lumateperone 42 mg capsule, oral administration
Lumateperone LAI
Lumateperone LAI (X500-E2 or X500-E3 or X500-X2 or X500-X5) IM injection
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 Capsule
Lumateperone 42 mg capsule, oral administration
Lumateperone LAI
Lumateperone LAI (X500-E2 or X500-E3 or X500-X2 or X500-X5) IM injection
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 Capsule
Lumateperone 42 mg capsule, oral administration
Lumateperone LAI
Lumateperone LAI (X500-E2 or X500-E3 or X500-X2 or X500-X5) IM injection
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 Capsule
Lumateperone 42 mg capsule, oral administration
Lumateperone LAI
Lumateperone LAI (X500-E2 or X500-E3 or X500-X2 or X500-X5) IM injection
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 Capsule
Lumateperone 42 mg capsule, oral administration
Lumateperone LAI
Lumateperone LAI (X500-E2 or X500-E3 or X500-X2 or X500-X5) IM injection
Interventions
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Lumateperone Capsule
Lumateperone 42 mg capsule, oral administration
Lumateperone LAI
Lumateperone LAI X500-E2 IM injection
Lumateperone LAI
Lumateperone LAI X500-E3 IM injection
Lumateperone LAI
Lumateperone LAI X500-X2 IM injection
Lumateperone LAI
Lumateperone LAI X500-X5 IM injection
Lumateperone LAI
Lumateperone LAI (X500-E2 or X500-E3 or X500-X2 or X500-X5) IM injection
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
55 Years
ALL
No
Sponsors
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Intra-Cellular Therapies, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Clinical Site 2
Role: primary
Clinical Site 3
Role: primary
Clinical Site 4
Role: primary
Clinical Site 1
Role: primary
Other Identifiers
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ITI-007-037
Identifier Type: -
Identifier Source: org_study_id
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