Who is sponsoring NCT04709224?

NCT04709224 is sponsored by Intra-Cellular Therapies, Inc..

What condition does NCT04709224 study?

NCT04709224 studies Schizophrenia.

What drugs are being tested in NCT04709224?

Interventions: Lumateperone Long-Acting Injectable.

What is the status of NCT04709224?

NCT04709224 is currently COMPLETED.

Last reviewed 2022-12-05 · How we verify

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

NCT04709224 PHASE1 COMPLETED

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.

Details

Lead sponsor	Intra-Cellular Therapies, Inc.
Phase	PHASE1
Status	COMPLETED
Enrolment	37
Start date	Wed Dec 30 2020 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Mon May 23 2022 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Schizophrenia

Interventions

Lumateperone Long-Acting Injectable

Countries

United States