ALXN2050 for Liver Dysfunction

Recruiting in Palo Alto (17 mi)

+3 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Alexion Pharmaceuticals, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults with varying degrees of liver dysfunction (Child-Pugh Classes A-C) and healthy controls matched by sex, race, age (+/- 10 years), and BMI (+/- 20%). Participants must not have liver cancer, be on a stable medication regimen, agree to use contraception and take antibiotics to prevent infection. Exclusions include fever or infection within 14 days before the study drug is given, recent blood donations or receipt of vaccines.

Inclusion Criteria

I am a healthy control with normal liver function, matching the sex, race, age (±10 years), and BMI (±20%) of the IHF participants.

I am healthy with normal liver function, confirmed by medical tests.

Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

+8 more

Exclusion Criteria

I haven't donated blood, received blood products, or had vaccines recently.

History or presence of drug or alcohol abuse within 6 months prior to the first dose of study intervention, current tobacco user, or positive results for alcohol and/or drug screen at screening or check-in.

Pregnant or lactating.

+6 more

Participant Groups

The trial studies how different levels of liver impairment affect the body's handling of ALXN2050. It aims to establish dosing guidelines for patients with impaired hepatic function. The study includes both those with liver issues and healthy individuals as controls to compare results.

1Treatment groups

Experimental Treatment

Group I: ALXN2050Experimental Treatment1 Intervention

Cohort 1: Mild IHR Cohort 2: Moderate IHR Cohort 3: Severe IHR Cohort 4: Healthy Control Participants will receive ALXN2050