Potential Drug Interaction Between ALXN2040 and Rosuvastatin

Alexion Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Rosuvastatin; Drug: ALXN2040

Study type: Interventional

Funder types: Industry

Identifiers

NCT05708573

ALXN2040-HV-102

Details and patient eligibility

About

This study will assess the potential drug-drug interaction (DDI) between ALXN2040 and rosuvastatin.

Full description

This is an open-label, 2-treatment, 2-period, fixed-sequence DDI study in healthy adult participants.

This study will comprise of:

• Screening duration of 27 days.
• Two treatment periods: Approximately 14 days. Treatment Period 1: 6 days Treatment Period 2: 8 days
• Follow-up: 7 (± 2) days following the final dose of study intervention.

There will be a washout period of at least 5 days between the single dose of rosuvastatin in Treatment Period 1 and the first dose of ALXN2040 in Treatment Period 2.

Each participant will be involved in the study for approximately 48 days.

Enrollment: 20 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Medically healthy participants with no clinically significant or relevant abnormalities as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory safety evaluation (hematology, biochemistry, coagulation, and urinalysis) that is reasonably likely to interfere with participation in or ability to complete the study, or to potentially confound interpretation of study results, as assessed by the Investigator.
• Body mass index (BMI) within the range 18 to 32 kg/m^2 (inclusive), with a minimum body weight of 50.0 kg at Screening.

Exclusion criteria

• History of any medical or psychiatric condition or disease that, in the opinion of the Investigator, might limit the participant's ability to complete or participate in this clinical study, confound the results of the study, or pose an additional risk to the participant by their participation in the study.
• History of meningococcal infection.
• History of drug or alcohol abuse within 2 years prior to first dose of study intervention, or positive drugs-of-abuse or alcohol screen at Screening or Day -1.
• Current tobacco users or smokers or a positive cotinine test at Screening.
• Any major surgery within 8 weeks of Screening.
• Donation of whole blood from 3 months prior to first dose, or of plasma from 30 days prior to first dose of study intervention.
• History of malignancy within 5 years prior to Screening.
• Evidence of human immunodeficiency virus (HIV) infection (HIV antibody positive) at Screening.
• Evidence of hepatitis B (positive hepatitis B surface antigen or positive core antibody with negative surface antibody) or hepatitis C viral infection (hepatitis C virus antibody positive) at Screening.
• Female participant who is pregnant, breastfeeding, or intending to conceive during the course of the study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Cohort 1

Experimental group

Description:

Participants will receive a single dose of rosuvastatin in the morning of Day 1 in Treatment Period 1. Following a washout period of 5 days, participants will receive ALXN2040 three times daily on Days 1 through 7 in treatment period 2.

Treatment:

Drug: Rosuvastatin

Drug: ALXN2040