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
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
Clinical Site 2
RECRUITING
Los Alamitos
Georgia
Clinical Site 3
RECRUITING
Atlanta
Clinical Site 4
RECRUITING
Decatur
New Jersey
Clinical Site 1
RECRUITING
Marlton
Contact Information
Primary
ITI Clinical Trials
ITCIClinicalTrials@itci-inc.com
6464409333
Time Frame
Start Date:2024-08-23
Estimated Completion Date:2026-03
Participants
Target number of participants:72
Treatments
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
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
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
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
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
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
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
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
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