Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2026-02-19 @ 3:18 PM
Study NCT ID:
NCT03627195
Status:
COMPLETED
Last Update Posted:
2020-05-08
First Post:
2018-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Determine the Maximum Tolerated Dose of an Investigational Drug in Subjects With Schizophrenia
Sponsor:
Sumitomo Pharma America, Inc.
Organization:
Study Overview
Official Title:
A Randomized, Double Blind, Placebo Controlled, Single Ascending Dose Study With Lurasidone Injectable Suspension to Evaluate Safety, Tolerability and Pharmacokinetics in Subjects With Schizophrenia
Status:
COMPLETED
Status Verified Date:
2020-04
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:
A study to determine the maximum tolerated dose of an investigational drug in subjects with schizophrenia
Detailed Description:
This is a single-center, randomized, double-blind, placebo-controlled, inpatient, single ascending dose (SAD) study designed to evaluate the safety, tolerability, and PK of lurasidone injectable suspension in subjects with schizophrenia. This study will determine the minimum intolerable dose (MID), the maximum tolerated dose (MTD) of lurasidone injectable suspension, and characterize the PK profiles of lurasidone and its metabolites in serum (ID-14283, ID-14326, ID-11614, ID-20219, and ID-20220) and urine (ID-14283, ID-14326, and ID-11614) in this subject population. The potential effects of gender on the PK of lurasidone injectable suspension and its metabolites will also be evaluated when applicable.
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?: