Marlton, New Jersey 08053

  • Schizophrenia

Purpose:

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 three 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.


Criteria:

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


Study is Available At:


Original ID:

ITI-007-025


NCT ID:

NCT04709224


Secondary ID:


Study Acronym:


Brief Title:

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


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


Overall Status:

Recruiting


Study Phase:

Phase 1


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

50 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Intra-Cellular Therapies, Inc.


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

24


Enrollment Type:

Anticipated


Overall Contact Information

Primary Contact:ITI Clinical Trials
646 440-9333
ITCIClinicalTrials@itci-inc.com

Study Dates

Start Date:December 30, 2020
Completion Date:December 2021
Completion Type:Anticipated
Primary Completion Date:November 2021
Primary Completion Type:Anticipated
Verification Date:December 2020
Last Changed Date:January 12, 2021
First Received Date:December 29, 2020

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Change from baseline in Abnormal Involuntary Movement Scale
Time Frame:up to 6 weeks postdose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from baseline in ECG QT Interval
Time Frame:up to 6 weeks postdose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from baseline in creatine kinase
Time Frame:up to 6 weeks postdose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from baseline in glucose
Time Frame:up to 6 weeks postdose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from baseline in alanine aminotransferase
Time Frame:up to 6 weeks postdose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from baseline in aspartate aminotransferase
Time Frame:up to 6 weeks postdose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from baseline in white blood cell count
Time Frame:up to 6 weeks postdose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from baseline in platelet count
Time Frame:up to 6 weeks postdose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from baseline in hemoglobin
Time Frame:up to 6 weeks postdose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from baseline in Systolic and Diastolic Blood Pressure
Time Frame:up to 6 weeks postdose
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Percentage of participants with treatment-emergent AEs
Time Frame:up to 6 weeks postdose
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Pharmacokinetics: Terminal elimination half-life (T1/2) of lumateperone and metabolites
Time Frame:predose and at multiple timepoints up to 6 weeks postdose
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Pharmacokinetics: Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-inf) of lumateperone and metabolites
Time Frame:predose and at multiple timepoints up to 6 weeks postdose
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Pharmacokinetics: Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t) of lumateperone and metabolites
Time Frame:predose and at multiple timepoints up to 6 weeks postdose
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Pharmacokinetics: Time of maximum observed plasma concentration (Tmax) of lumateperone and metabolites
Time Frame:predose and at multiple timepoints up to 6 weeks postdose
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Pharmacokinetics: Maximum observed plasma concentration (Cmax) of lumateperone and metabolites
Time Frame:predose and at multiple timepoints up to 6 weeks postdose
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Lumateperone Long-Acting Injectable
Description:Lumateperone Long-Acting Injectable
Arm Name:Cohort 1: LAI Lumateperone 50 mg

Study Arms

Study Arm Type:Experimental
Arm Name:Cohort 3: LAI Lumateperone 200 mg
Study Arm Type:Experimental
Arm Name:Cohort 2: LAI Lumateperone 100 mg
Study Arm Type:Experimental
Arm Name:Cohort 1: LAI Lumateperone 50 mg

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Intra-Cellular Therapies, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 25, 2021

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