Study of Oral ALXN1840 at 2 Dose Strengths in Healthy Adults

A Phase 1, Randomized, Open-Label, 2-Way Crossover Study to Assess the Single-Dose Pharmacokinetics of ALXN1840 Enteric-Coated Tablets at 2 Dose Strengths in Healthy Adult Subjects

To assess the relative bioavailability of ALXN1840 administered orally as a single enteric-coated (EC) tablet (reference, Treatment A) versus three EC tablets (test, Treatment B).

Inclusion Criteria:

• Body weight ≤ 100 kilograms (kg) and body mass index within the range 18-25 kg/meter squared, inclusive, at Screening.
• Negative serum pregnancy test at Screening and Day -1 for all women of childbearing potential.
• Willing to adhere to contraception requirements.
• Satisfactory medical assessment with no clinically significant or relevant abnormalities.

Exclusion Criteria:

• Current or recurrent/chronic disease
• Positive test for hepatitis B surface antigen or human immunodeficiency virus antibody at Screening.
• Acute or chronic hepatitis C virus infection.
• History of hypersensitivity to ALXN1840 or its excipients or any significant allergic reaction.
• Use of prescription medications (excluding oral contraceptives) within 14 days prior to dosing on Day 1, except with prior approval of the Sponsor.
• Participation (that is, last protocol-required study visit) in a clinical study within 90 days before initiation of dosing on Day 1.
• Serum ceruloplasmin value outside of the normal range at Screening
• Female participants who were breastfeeding.
• Prior exposure to ALXN1840.
• Major surgery or hospitalization within 90 days prior to dosing on Day 1.