Overview

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

Status:
Completed
Trial end date:
2014-03-24
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 Molybdenum.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Alexion Pharmaceuticals
Treatments:
Choline
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.