Pharmacokinetics, Safety, and Tolerability of Lumateperone Long-Acting Injectable in Patients With Schizophrenia

Schizophrenia Clinical Trial

Official title:

An Open-label Study to Determine the Pharmacokinetics, Safety and Tolerability of Single Ascending Doses of a Subcutaneous Injection of Lumateperone Long-Acting Injectable (LAI) Formulation in Patients With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04709224
• Other study ID #: ITI-007-025
• Status: Completed
• Phase: Phase 1
• Start date: December 30, 2020
• Est. completion date: May 23, 2022

Study information

• Verified date: December 2022
• Source: Intra-Cellular Therapies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label study to determine the pharmacokinetics, safety and tolerability of single ascending doses of lumateperone long-acting injectable formulation in patients with schizophrenia. Patients will be enrolled in one of up to four cohorts. All patients will receive oral lumateperone for 5 days, followed by a 5-day washout of oral lumateperone, then followed by a single dose of lumateperone LAI.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: May 23, 2022
• Est. primary completion date: May 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Key Inclusion Criteria:

• Male or female patients aged 18 to 50 years, inclusive
• Clinical diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
• Clinically stable and free from acute exacerbation of psychosis for at least 3 months prior to Screening per Investigator assessment
• On a stable dose of antipsychotic medication, including lumateperone, for at least 3 months prior to the Screening Visit
• Clinical Global Impression - Severity (CGI-S) score = 3

Key Exclusion Criteria:

• 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
• History of psychiatric condition other than schizophrenia that, in the Investigator's opinion, may be detrimental to participation in the study
• Any suicidal ideation within the 6 months prior to Screening, any suicidal behavior within 2 years prior to Screening 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
• Surgical or medical condition (active or chronic) that in the Investigator's opinion may interfere with drug absorption, distribution, metabolism, or excretion of the study drug or any other condition that may place the patient at risk; history of gastric bypass or sleeve gastrectomy; history of severe dystonic reaction on antipsychotics such as laryngeal spasm

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Lumateperone Long-Acting Injectable
Lumateperone Long-Acting Injectable

Locations

Country	Name	City	State
United States	Clinical Site	Long Beach	California
United States	Clinical Site	Marlton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Intra-Cellular Therapies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics: Maximum observed plasma concentration (Cmax) of lumateperone and metabolites		predose and at multiple timepoints up to 7 weeks postdose
Primary	Pharmacokinetics: Time of maximum observed plasma concentration (Tmax) of lumateperone and metabolites		predose and at multiple timepoints up to 7 weeks postdose
Primary	Pharmacokinetics: Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t) of lumateperone and metabolites		predose and at multiple timepoints up to 7 weeks postdose
Primary	Pharmacokinetics: Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-inf) of lumateperone and metabolites		predose and at multiple timepoints up to 7 weeks postdose
Primary	Pharmacokinetics: Terminal elimination half-life (T1/2) of lumateperone and metabolites		predose and at multiple timepoints up to 7 weeks postdose
Primary	Pharmacokinetics: Maximum observed plasma concentration (Cmax,BR) of lumateperone and metabolites during burst-release phase		predose and at multiple timepoints up to 7 weeks postdose
Primary	Pharmacokinetics: Time of maximum observed plasma concentration (Tmax,BR) of lumateperone and metabolites during burst-release phase		predose and at multiple timepoints up to 7 weeks postdose
Primary	Pharmacokinetics: Area under the plasma concentration-time curve (AUC0-t,BR) of lumateperone and metabolites during burst-release phase		predose and at multiple timepoints up to 7 weeks postdose
Primary	Pharmacokinetics: Maximum observed plasma concentration (Cmax,SR) of lumateperone and metabolites during sustained-release phase		predose and at multiple timepoints up to 7 weeks postdose
Primary	Pharmacokinetics: Time of maximum observed plasma concentration (Tmax,SR) of lumateperone and metabolites during sustained-release phase		predose and at multiple timepoints up to 7 weeks postdose
Primary	Pharmacokinetics: Area under the plasma concentration-time curve (AUC0-t,SR) of lumateperone and metabolites during sustained-release phase		predose and at multiple timepoints up to 7 weeks postdose
Secondary	Percentage of participants with treatment-emergent AEs		up to 7 weeks postdose
Secondary	Change from baseline in Systolic and Diastolic Blood Pressure		up to 7 weeks postdose
Secondary	Change from baseline in hemoglobin		up to 7 weeks postdose
Secondary	Change from baseline in platelet count		up to 7 weeks postdose
Secondary	Change from baseline in white blood cell count		up to 7 weeks postdose
Secondary	Change from baseline in aspartate aminotransferase		up to 7 weeks postdose
Secondary	Change from baseline in alanine aminotransferase		up to 7 weeks postdose
Secondary	Change from baseline in glucose		up to 7 weeks postdose
Secondary	Change from baseline in creatine kinase		up to 7 weeks postdose
Secondary	Change from baseline in ECG QT Interval		up to 7 weeks postdose
Secondary	Change from baseline in Abnormal Involuntary Movement Scale	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).	up to 7 weeks postdose