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

Study Identifier:
WTX101-101
ClinicalTrials.gov Identifier:
NCT05319899
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Other
Study Drug
  • Drug: ALXN1840
  • Drug: Omeprazole
Date
Jan 2014 - Mar 2014
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 19 - 55 Years
Requirements Information
Inclusion and Exclusion 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.
Sex
Female & Male
Age
19 - 55 Years

Study Details

Medical Condition
  • Other
Study Drug
  • Drug: ALXN1840
  • Drug: Omeprazole
Date
Jan 2014 - Mar 2014
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 19 - 55 Years years
Requirements Information
Inclusion and Exclusion 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.

Protocol 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.

Trial Locations

Location
Status
Location
Clinical Trial Site
Lincoln, Nebraska, United States, 68502
Status
N/A