Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT06747520
Status:
COMPLETED
Last Update Posted:
2024-12-27
First Post:
2024-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase 1 Renal Insufficiency Trial of Methoxyethyl Etomidate Hydrochloride
Sponsor:
Ahon Pharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase I Clinical Trial Assessing the Safety and Pharmacokinetics of a Single Intravenous Administration of Methoxetamine Hydrochloride in Subjects With Mild to Moderate Renal Impairment Compared to Individuals With Normal Renal Function
Status:
COMPLETED
Status Verified Date:
2024-12
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:
Twenty-four subjects were divided into three groups: subjects with mild renal insufficiency, subjects with moderate renal insufficiency and subjects with normal renal function, with 8 subjects in each group.Subjects with mild renal insufficiency and moderate renal insufficiency were enrolled first, and then subjects with normal renal function were matched according to age, weight and gender. All patients received a single intravenous injection of 0.8mg/kg ET-26. To compare the pharmacokinetic characteristics of ET-26 and etomidate acid in subjects with mild and moderate renal insufficiency and normal renal function, and to provide clinical guidance for the use of ET-26 in patients with mild and moderate renal insufficiency.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: