Potential Drug Interaction Between ALXN2040 and Rosuvastatin

Completed · Phase 1

Conditions studied: Healthy Participants

In brief

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

Key facts

Study ID

NCT05708573

Run by

Alexion Pharmaceuticals, Inc.

People needed

20

Starts

2023-02-01

Expected to finish

2023-04-05

Last updated by the study team

2023-04-14

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Clinical Trial Site — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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