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Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizophrenia or Schizoaffective Disorder

Purpose

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.

Condition

Schizophrenia or Schizoaffective

Eligibility

Eligible Ages: Between 18 Years and 55 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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

Phase: Phase 1
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
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	Drug: Lumateperone Capsule Lumateperone 42 mg capsule, oral administration Drug: Lumateperone LAI Lumateperone LAI X500-E2 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	Drug: Lumateperone Capsule Lumateperone 42 mg capsule, oral administration Drug: Lumateperone LAI Lumateperone LAI X500-E3 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	Drug: Lumateperone Capsule Lumateperone 42 mg capsule, oral administration Drug: Lumateperone LAI Lumateperone LAI X500-X2 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	Drug: Lumateperone Capsule Lumateperone 42 mg capsule, oral administration Drug: Lumateperone LAI Lumateperone LAI 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	Drug: Lumateperone Capsule Lumateperone 42 mg capsule, oral administration Drug: Lumateperone LAI 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	Drug: Lumateperone Capsule Lumateperone 42 mg capsule, oral administration Drug: Lumateperone LAI 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	Drug: Lumateperone Capsule Lumateperone 42 mg capsule, oral administration Drug: Lumateperone LAI 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	Drug: Lumateperone Capsule Lumateperone 42 mg capsule, oral administration Drug: Lumateperone LAI 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	Drug: Lumateperone Capsule Lumateperone 42 mg capsule, oral administration Drug: Lumateperone LAI Lumateperone LAI (X500-E2 or X500-E3 or X500-X2 or X500-X5) IM injection

Recruiting Locations

Clinical Site 2
Los Alamitos 5368304, California 5332921 90720

Contact:
Clinical Site 2

Clinical Site 3
Atlanta 4180439, Georgia 4197000 30331

Contact:
Clinical Site 3

Clinical Site 4
Decatur 4191124, Georgia 4197000 30030

Contact:
Clinical Site 4

Clinical Site 1
Marlton 4502911, New Jersey 5101760 08053

Contact:
Clinical Site 1

More Details

NCT ID: NCT06627413
Status: Recruiting
Sponsor: Intra-Cellular Therapies, Inc.

Study Contact

ITI Clinical Trials
6464409333
ITCIClinicalTrials@itci-inc.com