Status:
COMPLETED
Pharmacokinetics, Safety, and Tolerability of Lumateperone Long-Acting Injectable in Patients With Schizophrenia
Lead Sponsor:
Intra-Cellular Therapies, Inc.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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. Pati...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
December 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2022
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT04709224
Start Date
December 30 2020
End Date
May 23 2022
Last Update
December 5 2022
Active Locations (2)
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1
Clinical Site
Long Beach, California, United States, 90806
2
Clinical Site
Marlton, New Jersey, United States, 08053