Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04786730
Status:
COMPLETED
Last Update Posted:
2023-07-13
First Post:
2021-02-25
Brief Title:
A Trial to Assess the Pharmacokinetics Safety and Tolerability of Centanafadine Capsules in Pediatric Subjects With Attention-deficit Hyperactivity Disorder
Sponsor:
Otsuka Pharmaceutical Development Commercialization Inc
Organization:
Otsuka Pharmaceutical Development Commercialization Inc
Study Overview
Official Title:
A Phase 1b Multicenter Open-label Multiple Ascending Dose Trial to Assess the Pharmacokinetics Safety and Tolerability of Centanafadine Extended-release Capsules After Oral Administration in Pediatric Subjects 4 to 12 Years Inclusive With Attention-deficit Hyperactivity Disorder
Status:
COMPLETED
Status Verified Date:
2023-07
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 a phase 1b multicenter open-label multiple-dose trial in pediatric subjects 4 - 12 years of age inclusive with a confirmed diagnosis of ADHD
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