A Study of ALXN1840 (Coated and Non-coated) Administered With And Without Omeprazole In Healthy Adults

A Phase 1, Single-Center, Randomized, 3-Period Crossover Study in Healthy Volunteers to Evaluate the Absorption of WTX101 After Single Dose Administration of an Enteric Coated Formulation With and Without Food and a Non-Coated Formulation Coadministered With a Proton Pump Inhibitor Without Food

This was single-center, open-label, randomized, 3-period, 3-treatment, 6-sequence crossover study evaluating the PK of single doses of WTX101 in healthy participants based on the measurement of plasma total Mo concentration.

Inclusion Criteria:

• Non-smoker
• Medically healthy with no clinically significant laboratory profiles, vital signs, or electrocardiograms.
• Body mass index ≥ 18 and ≤ 32.0 kilograms/meter squared.
• Willing and able to adhere to contraception requirements.

Exclusion Criteria:

• Participant was mentally or legally incapacitated
• History or presence of clinically significant medical or psychiatric condition or disease.
• History of any illness that might have interfered with drug absorption.
• History or presence of hypersensitivity or idiosyncratic reaction to the study medications, study medication excipients.
• History or presence of alcoholism or drug abuse.
• Female participants who were pregnant or lactating.
• Positive results at screening for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus.
• Serum ceruloplasmin and copper values outside of the normal range at screening.
• On a diet incompatible with the on-study diet within the 28 days prior to the first ALXN1840 dose and throughout the study; unable to consume the contents of a high-fat breakfast.
• Participation in a previous clinical trial with ALXN1840.