NCT05259085

Study of ALXN2050 in Participants With Hepatic Impairment

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Impaired Hepatic Function
• Healthy

Interventions

Type	Name	Description
DRUG	ALXN2050	ALXN2050 (120 milligrams) will be administered orally twice daily on Days 1 through 3, with an additional dose (120 milligrams) administered orally on the morning of Day 4.

Timeline

• Start date: 2022-04-07
• Primary completion: 2024-08-12
• Completion: 2024-08-12
• First posted: 2022-02-28
• Last updated: 2025-03-19

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study