Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-01-17 @ 8:52 AM
Study NCT ID:
NCT05321602
Status:
COMPLETED
Last Update Posted:
2024-03-19
First Post:
2021-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder
Sponsor:
Luye Pharma Group Ltd.
Organization:
Study Overview
Official Title:
A Randomized, Single-Dose, Open-Label, Parallel-Group Study to Evaluate the Pharmacokinetic Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder
Status:
COMPLETED
Status Verified Date:
2024-03
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 randomized, single-dose, open-label, parallel-group study. Patients will undergo the screening evaluations to determine eligibility within 28 days prior to study drug administration. Approximately 80 eligible patients will be randomized in a 1:1:1:1 ratio to 1 of 4 treatment groups.
Detailed Description:
This is a randomized, single-dose, open-label, parallel-group study. Patients will undergo the screening evaluations to determine eligibility within 28 days prior to study drug administration. Approximately 80 eligible patients will be randomized in a 1:1:1:1 ratio to 1 of 4 treatment groups.
Patients will be admitted to the clinical facilities the day (Day 0) before dosing, and will be randomized and receive a single dose on Day 1. Patients will be discharged on Day 2 after PK collection. All patients will return to the clinical site at designated study days for PK sample collections and assigned clinical procedures (Table 1). End of study evaluation will be completed on Day 176 or at early withdrawal.
For patients who have never taken paliperidone or risperidone, tolerability will be tested with oral risperidone (1 mg risperidone taken orally for 3 consecutive days) at Screening approximately 14 days but no less than 9 days prior to dosing.
Patients will be admitted to the clinical facilities the day (Day 0) before dosing, and will be randomized and receive a single dose on Day 1. Patients will be discharged on Day 2 after PK collection. All patients will return to the clinical site at designated study days for PK sample collections and assigned clinical procedures (Table 1). End of study evaluation will be completed on Day 176 or at early withdrawal.
For patients who have never taken paliperidone or risperidone, tolerability will be tested with oral risperidone (1 mg risperidone taken orally for 3 consecutive days) at Screening approximately 14 days but no less than 9 days prior to dosing.
Study Oversight
Has Oversight DMC:
False
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?: