A Phase 1 interventional study of Lumateperone Capsule and Lumateperone LAI in Schizophrenia or Schizoaffective, sponsored by Intra-Cellular Therapies, Inc.. Completed at 4 sites in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by Intra-Cellular Therapies, Inc. · Phase 1, Interventional, and Treatment
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.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 52 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Intra-Cellular Therapies, Inc. is the lead sponsor of 40 studies on the registry; 12 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 10 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
Main Inclusion Criteria:
Main Exclusion Criteria:
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 · Drug: Lumateperone LAI
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 · Drug: Lumateperone LAI
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 · Drug: Lumateperone LAI
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 · Drug: Lumateperone LAI
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 · Drug: Lumateperone LAI
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 · Drug: Lumateperone LAI
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 · Drug: Lumateperone LAI
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 · Drug: Lumateperone LAI
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 · Drug: Lumateperone LAI
Lumateperone 42 mg capsule, oral administration
Lumateperone LAI X500-E2 IM injection
Lumateperone LAI X500-E3 IM injection
Lumateperone LAI X500-X2 IM injection
Lumateperone LAI X500-X5 IM injection
Lumateperone LAI (X500-E2 or X500-E3 or X500-X2 or X500-X5) IM injection
Pharmacokinetics: Cmax,oral
Maximum plasma concentration of lumateperone
Time frame: Day 5
Pharmacokinetics: Cmax,IM
Maximum plasma concentration of lumateperone
Time frame: Day 11-60
Pharmacokinetics: Tmax,oral
Time of maximum concentration of lumateperone in plasma
Time frame: Day 5
Pharmacokinetics: Tmax,IM
Time of maximum concentration of lumateperone in plasma
Time frame: Day 11-60
Pharmacokinetics: AUC0-t,oral
Area under the plasma concentration time curve from time zero to the last measurable of concentration of lumateperone
Time frame: Day 5
Pharmacokinetics: AUC0-t,IM
Area under the plasma concentration time curve from time zero to the last measurable of concentration of lumateperone
Time frame: Day 11-60
Percentage of subjects with treatment-emergent adverse events
Time frame: up to 30 days after the last protocol-defined study visit
Change from baseline in systolic and diastolic blood pressure
Time frame: Days 25 and 60
Change from baseline in ECG QTcF interval
Time frame: Days 25 and 60
Change from baseline in hemoglobin
Time frame: Days 25 and 60
Change from baseline in white blood cell count
Time frame: Days 25 and 60
Change from baseline in aspartate aminotransferase
Time frame: Days 25 and 60
Change from baseline in alanine aminotransferase
Time frame: Days 25 and 60
Change from baseline in Abnormal Involuntary Movement Scale (AIMS)
AIMS is a measure of facial and oral movements, extremity movements and trunk movements. Items are rated on a scale from none (0) to severe (4).
Time frame: Days 25 and 60
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Intra-Cellular Therapies, Inc.