Ignite Creation Date:
2024-05-06 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04709224
Status:
COMPLETED
Last Update Posted:
2022-12-05
First Post:
2020-12-29
Brief Title:
Pharmacokinetics Safety and Tolerability of Lumateperone Long-Acting Injectable in Patients With Schizophrenia
Sponsor:
Intra-Cellular Therapies Inc
Organization:
Intra-Cellular Therapies Inc
Study Overview
Official Title:
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
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None