NCT04709224

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Intra-Cellular Therapies, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Lumateperone Long-Acting Injectable	Lumateperone Long-Acting Injectable

Timeline

• Start date: 2020-12-30
• Primary completion: 2022-05-23
• Completion: 2022-05-23
• First posted: 2021-01-14
• Last updated: 2022-12-05

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study