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Pharmacokinetic and Pharmacodynamic Study of AMX0035 in Patients With ALS

ALS Clinical Trial

Official title:
A Pharmacokinetic and Pharmacodynamic Study of AMX0035 in Patients With ALS

Clinical Trial Summary

The purpose of this study is to evaluate the pharmacokinetic and pharmacodynamic effect after a single dose or at steady state after multiple doses of AMX0035 in adults with sporadic ALS.

Clinical Trial Description

AMX0035 is a proprietary combination of two small molecules, phenylbutyrate (PB) and taurursodiol. The combination of PB and taurursodiol in AMX0035 is intended to block neuronal death and neurotoxic inflammation through simultaneous reduction of endoplasmic reticulum (ER) stress and mitochondrial stress. The pharmacokinetic of AMX0035 has been evaluated in healthy volunteers. This Phase IIa trial is intended to evaluate pharmacokinetic of PB and taurursodiol upon single dose multiple dose administration of AMX0035 in patients with ALS. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04987671
Study type Interventional
Source Amylyx Pharmaceuticals Inc.
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date August 5, 2021
Completion date September 2023
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