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

• Status: Completed
• Trial end date: 2014-05-29
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alexion Pharmaceuticals
• Treatments: Choline; Molybdenum; Omeprazole; Tetrathiomolybdate

Criteria

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.