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

Completed · Phase 1

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID
NCT04709224
Run by
Intra-Cellular Therapies, Inc.
People needed
37
Starts
2020-12-30
Expected to finish
2022-05-23
Last updated by the study team
2022-12-05

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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