Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06627413
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-02
Brief Title:
Safety Tolerability and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizophrenia or Schizoaffective Disorder
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1b Open-label Study to Determine the Pharmacokinetics Safety and Tolerability of Single Ascending Doses of Lumateperone Long-acting Injectable Formulations Administered Intramuscularly to Patients With Schizophrenia or Schizoaffective Disorder
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study ITI-007-037 is a Phase 1b open-label study to evaluate the safety tolerability and PK of lumateperone long-acting injectable LAI formulations after a single intramuscular injection in patients with stale schizophrenia or schizoaffective disorder
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None