NCT06747520

Phase 1 Renal Insufficiency Trial of Methoxyethyl Etomidate Hydrochloride

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Ahon Pharmaceutical Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Renal Insufficiency

Interventions

Type	Name	Description
DRUG	ET-26HCl	The dose is 0.8 mg/kg, single dose, Infusion time was 60s ± 5s.

Timeline

• Start date: 2023-11-30
• Primary completion: 2024-02-21
• Completion: 2024-02-28
• First posted: 2024-12-24
• Last updated: 2024-12-27

Locations

1 site across 1 country: China