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

Primary Purpose

Schizophrenia

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Lumateperone Long-Acting Injectable

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Clinical Site
Clinical Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Cohort 1: LAI Lumateperone 50 mg SC in the abdomen

Cohort 2: LAI Lumateperone 100 mg SC in the abdomen

Cohort 3: LAI Lumateperone 200 mg SC in the abdomen

Cohort 4: LAI Lumateperone 100 or 200 mg SC in the outer area of the upper arm

Arm Description

Outcomes

Primary Outcome Measures

Pharmacokinetics: Maximum observed plasma concentration (Cmax) of lumateperone and metabolites

Pharmacokinetics: Time of maximum observed plasma concentration (Tmax) of lumateperone and metabolites

Pharmacokinetics: Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t) of lumateperone and metabolites

Pharmacokinetics: Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-inf) of lumateperone and metabolites

Pharmacokinetics: Terminal elimination half-life (T1/2) of lumateperone and metabolites

Pharmacokinetics: Maximum observed plasma concentration (Cmax,BR) of lumateperone and metabolites during burst-release phase

Pharmacokinetics: Time of maximum observed plasma concentration (Tmax,BR) of lumateperone and metabolites during burst-release phase

Pharmacokinetics: Area under the plasma concentration-time curve (AUC0-t,BR) of lumateperone and metabolites during burst-release phase

Pharmacokinetics: Maximum observed plasma concentration (Cmax,SR) of lumateperone and metabolites during sustained-release phase

Pharmacokinetics: Time of maximum observed plasma concentration (Tmax,SR) of lumateperone and metabolites during sustained-release phase

Pharmacokinetics: Area under the plasma concentration-time curve (AUC0-t,SR) of lumateperone and metabolites during sustained-release phase

Secondary Outcome Measures

Percentage of participants with treatment-emergent AEs

Change from baseline in Systolic and Diastolic Blood Pressure

Change from baseline in hemoglobin

Change from baseline in platelet count

Change from baseline in white blood cell count

Change from baseline in aspartate aminotransferase

Change from baseline in alanine aminotransferase

Change from baseline in glucose

Change from baseline in creatine kinase

Change from baseline in ECG QT Interval

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).

Full Information

NCT ID

NCT04709224

First Posted

December 29, 2020

Last Updated

December 1, 2022

Sponsor

Intra-Cellular Therapies, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04709224

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

December 30, 2020 (Actual)

Primary Completion Date

May 23, 2022 (Actual)

Study Completion Date

May 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Intra-Cellular Therapies, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1: LAI Lumateperone 50 mg SC in the abdomen

Arm Type

Experimental

Arm Title

Cohort 2: LAI Lumateperone 100 mg SC in the abdomen

Arm Type

Experimental

Arm Title

Cohort 3: LAI Lumateperone 200 mg SC in the abdomen

Arm Type

Experimental

Arm Title

Cohort 4: LAI Lumateperone 100 or 200 mg SC in the outer area of the upper arm

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Lumateperone Long-Acting Injectable

Intervention Description

Lumateperone Long-Acting Injectable

Primary Outcome Measure Information:

Title

Pharmacokinetics: Maximum observed plasma concentration (Cmax) of lumateperone and metabolites

Time Frame