A Research Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DUR-928 in Patients With Alcoholic Hepatitis

Phase 2 Completed 19 enrolled Durect CTI Clinical Trial and Consulting Services · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a research trial testing DUR-928 (an experimental medication). The purpose of this trial is to assess the dose related safety, Pharmacokinetics, and Pharmacodynamics of DUR 928 in patients with moderate and severe alcoholic hepatitis (AH).

Timeline

Start: 2018-04-18
Primary completion: 2019-09-09
Completion: 2019-09-09

Publications

Hassanein T, McClain CJ, Vatsalya V, Stein LL, Flamm SL, Martin P, Cave MC, Mitchell M Jr, Barton B, Nagy L, Szabo G, McCullough A, Dasarathy S, Shah J, Blevins C, Scott D, Krebs W, Brown JE, Lin W. Safety, Pharmacokinetics, and Efficacy Signals of Larsucosterol (DUR-928) in Alcohol-Associated Hepatitis. Am J Gastroenterol. 2024 Jan 1;119(1):107-115. doi: 10.14309/ajg.0000000000002275. Epub 2023 Apr 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Larsucosterol	Small molecule	30 mg	Intravenous
Subject	Larsucosterol	Small molecule	90 mg	Intravenous
Subject	Larsucosterol	Small molecule	150 mg	Intravenous

A Research Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DUR-928 in Patients With Alcoholic Hepatitis

Summary

Timeline

Publications

Drugs

Indications