Status:
COMPLETED
A Study of ALXN1840 (Non-coated) Administered With And Without Omeprazole In Healthy Adults
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Conditions:
Healthy
Eligibility:
All Genders
19-55 years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 20 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2014
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT05319899
Start Date
January 20 2014
End Date
March 24 2014
Last Update
August 1 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinical Trial Site
Lincoln, Nebraska, United States, 68502