Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06557902
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
Safety Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-label Multiple-dose Study to Evaluate the Pharmacokinetics Safety and Tolerability of Lumateperone in Pediatric Patients Ages 5 to Less Than 13 Years Diagnosed With Autism Spectrum Disorder
Status:
RECRUITING
Status Verified Date:
2024-08
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-007-035 is a Phase 1b multicenter open-label study to evaluate the safety tolerability and PK of lumateperone for pediatric patients with Autism Spectrum 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