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Study of ALXN2050 in Participants With Hepatic Impairment

Healthy Clinical Trial

Official title:
A Phase 1, Open-Label, Multiple-Dose, Parallel Study to Determine the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of ALXN2050 in Adult Participants

Clinical Trial Summary

This study will investigate the impact of impaired hepatic function (IHF) on the plasma pharmacokinetics of ALXN2050 in order to provide dosing recommendations for future indications in individuals with varying degrees of IHF.

Clinical Trial Description

The study will initiate (Part 1) with participants with mild IHF (Cohort 1) and moderate IHF (Cohort 2) and their matched healthy control participants (Cohort 4). Cohort 1 will be enrolled first, and following an adequate safety review, enrollment for Cohort 2 will begin. Following data review, the study may proceed (Part 2) with participants with severe IHF (Cohort 3) if deemed necessary. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05259085
Study type Interventional
Source Alexion
Contact Alexion Pharmaceuticals, Inc.
Phone 855-752-2356
Email clinicaltrials@alexion.com
Status Recruiting
Phase Phase 1
Start date April 7, 2022
Completion date October 15, 2024
View Details
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