Status:
COMPLETED
Phase 1 Study of ALXN1840 on the Metabolism of a CYP2C9 Substrate in Healthy Participants.
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Conditions:
Wilson Disease
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
This was a Phase 1, randomized, 2-period, 2-sequence, cross-over study designed to determine the effect of ALXN1840 on the metabolism of celecoxib, a sensitive cytochrome P450 2C9 (CYP2C9) substrate, ...
Detailed Description
The study was conducted as a randomized, 2-period, 2-sequence, cross-over study to determine the effect of a single dose of ALXN1840 (perpetrator) on the single-dose celecoxib (victim) kinetics in hea...
Eligibility Criteria
Inclusion
- Adequate venous access in the left or right arm to allow the collection of blood samples.
- Bodyweight ≥ 45 to ≤ 100 kilograms (kg) and body mass index within the range of 18 to \< 30 kg/meter squared.
- Willing and able to follow protocol-specified contraception requirements.
- Capable of giving signed informed consent.
Exclusion
- History or presence of/significant medical history.
- Clinically significant multiple or severe allergies.
- Lymphoma, leukemia, or any malignancy within 5 years.
- Breast cancer within the past 10 years.
- Serum creatinine \> upper limit of normal (ULN) of the reference range.
- Alanine aminotransferase, aspartate aminotransferase, or total bilirubin \> ULN.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- QTc \> 450 milliseconds (msec) for male participants or \> 470 msec for female participants.
Key Trial Info
Start Date :
July 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 3 2020
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04526197
Start Date
July 7 2020
End Date
November 3 2020
Last Update
August 21 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinical Trial Site
Austin, Texas, United States, 78744