Status:
COMPLETED
Study of Oral ALXN1840 at 2 Dose Strengths in Healthy Adults
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
To assess the relative bioavailability of ALXN1840 administered orally as a single enteric-coated (EC) tablet (reference, Treatment A) versus three EC tablets (test, Treatment B).
Eligibility Criteria
Inclusion
- Body weight ≤ 100 kilograms (kg) and body mass index within the range 18-25 kg/meter squared, inclusive, at Screening.
- Negative serum pregnancy test at Screening and Day -1 for all women of childbearing potential.
- Willing to adhere to contraception requirements.
- Satisfactory medical assessment with no clinically significant or relevant abnormalities.
Exclusion
- Current or recurrent/chronic disease
- Positive test for hepatitis B surface antigen or human immunodeficiency virus antibody at Screening.
- Acute or chronic hepatitis C virus infection.
- History of hypersensitivity to ALXN1840 or its excipients or any significant allergic reaction.
- Use of prescription medications (excluding oral contraceptives) within 14 days prior to dosing on Day 1, except with prior approval of the Sponsor.
- Participation (that is, last protocol-required study visit) in a clinical study within 90 days before initiation of dosing on Day 1.
- Serum ceruloplasmin value outside of the normal range at Screening
- Female participants who were breastfeeding.
- Prior exposure to ALXN1840.
- Major surgery or hospitalization within 90 days prior to dosing on Day 1.
Key Trial Info
Start Date :
July 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 9 2019
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05303324
Start Date
July 4 2019
End Date
October 9 2019
Last Update
August 2 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinical Trial Site
London, United Kingdom, SE11YR