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

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT05319912

Run by

Alexion Pharmaceuticals, Inc.

People needed

18

Starts

2014-04-07

Expected to finish

2014-05-29

Last updated by the study team

2023-08-02

Who can join

Age: 19 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Clinical Trial Site — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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