Clinical trial NCT06627413: Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizophrenia or Schizoaffective Disorder
Official title: 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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Schizophrenia or Schizoaffective
Lead sponsor: Intra-Cellular Therapies, Inc.
Sponsor class: INDUSTRY
First posted: 2024-10-04
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.


Eligibility 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.

Primary outcomes:
measure: Pharmacokinetics: Cmax,oral
timeFrame: Day 5
measure: Pharmacokinetics: Cmax,IM
timeFrame: Day 11-60
measure: Pharmacokinetics: Tmax,oral
timeFrame: Day 5
measure: Pharmacokinetics: Tmax,IM
timeFrame: Day 11-60
measure: Pharmacokinetics: AUC0-t,oral
timeFrame: Day 5
measure: Pharmacokinetics: AUC0-t,IM
timeFrame: Day 11-60
Secondary outcomes:
measure: Percentage of subjects with treatment-emergent adverse events
timeFrame: up to 30 days after the last protocol-defined study visit
measure: Change from baseline in systolic and diastolic blood pressure
timeFrame: Days 25 and 60
measure: Change from baseline in ECG QTcF interval
timeFrame: Days 25 and 60
measure: Change from baseline in hemoglobin
timeFrame: Days 25 and 60
measure: Change from baseline in white blood cell count
timeFrame: Days 25 and 60
measure: Change from baseline in aspartate aminotransferase
timeFrame: Days 25 and 60
measure: Change from baseline in alanine aminotransferase
timeFrame: Days 25 and 60
measure: Change from baseline in Abnormal Involuntary Movement Scale (AIMS)
timeFrame: Days 25 and 60
Other outcomes:
Locations:
city: Los Alamitos
country: United States
facility: Clinical Site 2
state: California
city: Atlanta
country: United States
facility: Clinical Site 3
state: Georgia
city: Decatur
country: United States
facility: Clinical Site 4
state: Georgia
city: Marlton
country: United States
facility: Clinical Site 1
state: New Jersey
Study officials:
References: