NCT06627413View on ClinicalTrials.gov

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

PHASE1RecruitingINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

August 23, 2024

Primary Completion Date

February 28, 2026

Study Completion Date

March 31, 2026

Conditions
Schizophrenia or Schizoaffective
Interventions
DRUG

Lumateperone Capsule

Lumateperone 42 mg capsule, oral administration

DRUG

Lumateperone LAI

Lumateperone LAI X500-E2 IM injection

DRUG

Lumateperone LAI

Lumateperone LAI X500-E3 IM injection

DRUG

Lumateperone LAI

Lumateperone LAI X500-X2 IM injection

DRUG

Lumateperone LAI

Lumateperone LAI X500-X5 IM injection

DRUG

Lumateperone LAI

Lumateperone LAI (X500-E2 or X500-E3 or X500-X2 or X500-X5) IM injection

Trial Locations (4)

30030

RECRUITING

Clinical Site 4, Decatur

30331

RECRUITING

Clinical Site 3, Atlanta

90720

RECRUITING

Clinical Site 2, Los Alamitos

08053

RECRUITING

Clinical Site 1, Marlton

Sponsors
All Listed Sponsors
lead

Intra-Cellular Therapies, Inc.

INDUSTRY