ALXN2050 for Liver Dysfunction

Recruiting at 3 trial locations

Overseen By Alexion Pharmaceuticals, Inc. (Sponsor)

Age: Any Age

Sex: Any

Trial Phase: Phase 1

Sponsor: Alexion Pharmaceuticals, Inc.

Must be taking: Prophylactic antibiotics

Disqualifiers: Seizures, Brain disorder, Alcohol abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Varies by cohort

26 Participants Needed

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple doses of ALXN2050 to assess pharmacokinetics, safety, and tolerability

Varies by cohort

Safety Review

Safety data is reviewed to determine progression to the next cohort

Not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ALXN2050

Trial Overview 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.

Participant Groups

Group I: ALXN2050 Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Alexion Pharmaceuticals, Inc.

Lead Sponsor

Trials

267

Recruited

141,000+

Dr. Alberto R. Martinez

Alexion Pharmaceuticals, Inc.

Chief Medical Officer since 2010

MD from University of Sao Paulo

Marc Dunoyer

Alexion Pharmaceuticals, Inc.

Chief Executive Officer since 2021

PhD in Molecular Biology

Alexion Pharmaceuticals

Lead Sponsor

Trials

231

Recruited

36,700+

Marc Dunoyer

Alexion Pharmaceuticals

Chief Executive Officer since 2021

B.A. in Psychology from the University of New Hampshire

Christophe Hotermans

Alexion Pharmaceuticals

Chief Medical Officer since 2023

MD

Alexion

Lead Sponsor

Trials

247

Recruited

38,600+

Marc Dunoyer

Alexion

Chief Executive Officer since 2021

PhD in Molecular Biology, University of Brussels

Christophe Hotermans

Alexion

Chief Medical Officer since 2021

MD, University of Leuven