Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05779241
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2023-03-09
Brief Title:
Study to Evaluate the Pharmacokinetics PK and SafetyTolerability of Long-Acting Oral LYN-005
Sponsor:
Lyndra Inc
Organization:
Lyndra Inc
Study Overview
Official Title:
A Multi Dose Open-Label Parallel-Group Study to Evaluate the PK and SafetyTolerability of Long-Acting Oral Risperidone LYN-005 in Participants With Schizophrenia or Schizoaffective Disorder
Status:
COMPLETED
Status Verified Date:
2024-10
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:
Lyndra Therapeutics Inc is developing LYN-005 a long-acting oral LAO capsule LYNX dosage form of risperidone This pivotal study LYN-005-C-301 will evaluate the PK as well as safety and tolerability of multiple administrations of the LYN-005 formulation at two dose levels
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