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Atypical Antipsychotic

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

Phase 1
Waitlist Available
Research Sponsored by Intra-Cellular Therapies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 weeks postdose
Awards & highlights

Study Summary

This study is evaluating whether a new drug may help treat schizophrenia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 weeks postdose
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 weeks postdose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmacokinetics: Area under the plasma concentration-time curve (AUC0-t,BR) of lumateperone and metabolites during burst-release phase
Pharmacokinetics: Area under the plasma concentration-time curve (AUC0-t,SR) of lumateperone and metabolites during sustained-release phase
Pharmacokinetics: Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-inf) of lumateperone and metabolites
+8 more
Secondary outcome measures
Change from baseline in Abnormal Involuntary Movement Scale
Change from baseline in ECG QT Interval
Change from baseline in Systolic and Diastolic Blood Pressure
+8 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort 4: LAI Lumateperone 100 or 200 mg SC in the outer area of the upper armExperimental Treatment1 Intervention
Group II: Cohort 3: LAI Lumateperone 200 mg SC in the abdomenExperimental Treatment1 Intervention
Group III: Cohort 2: LAI Lumateperone 100 mg SC in the abdomenExperimental Treatment1 Intervention
Group IV: Cohort 1: LAI Lumateperone 50 mg SC in the abdomenExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lumateperone Long-Acting Injectable
2020
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

Intra-Cellular Therapies, Inc.Lead Sponsor
29 Previous Clinical Trials
7,110 Total Patients Enrolled
10 Trials studying Schizophrenia
2,351 Patients Enrolled for Schizophrenia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Pharmacokinetics, Safety, and Tolerability of Lumateperone Long-Acting Injectable in Patients With Schizophrenia
2020. "Pharmacokinetics, Safety, and Tolerability of Lumateperone Long-Acting Injectable in Patients With Schizophrenia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04709224.
~9 spots leftby Apr 2025
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