NCT04623710

Study of ALXN2050 in Participants With Renal Impairment

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This study will investigate the impact of impaired renal function on the plasma pharmacokinetics of ALXN2050 in order to provide dosing recommendations for future indications in individuals with impaired renal function.

Detailed description

The study will initiate (Part 1) with participants with severe impaired renal function (Cohort 1) and their matched healthy control participants (Cohort 4). Following data review, the study may proceed (Part 2) with participants with moderate (Cohort 2) and mild (Cohort 3) impaired renal function if deemed necessary.

Conditions

• Renal Impairment
• 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: 2021-07-08
• Primary completion: 2022-02-18
• Completion: 2022-03-21
• First posted: 2020-11-10
• Last updated: 2023-09-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study