Copper Concentration and Histopathologic Changes in Liver Biopsy in Participants With Wilson Disease Treated With ALXN1840
Active, not recruiting
Alexion Pharmaceuticals
Phase 2
The main objective of the study is to evaluate the change in liver copper (Cu) concentration
following 48 weeks of treatment with ALXN1840 in adult participants with Wilson Disease (WD)
who have been previously treated for at least 1 year with standard of care (that is,
trientine, penicillamine, or zinc). In the Treatment Period, efficacy and safety of ALXN1840
will be assessed at Week 48.
Phase 1 Study of ALXN1840 on the Metabolism of a CYP2C9 Substrate in Healthy Participants.
Completed
Alexion Pharmaceuticals
Phase 1
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, in healthy male and female participants. The safety and tolerability of
ALXN1840 were determined along with ALXN1840 pharmacokinetics (PK) in plasma as measured via
total molybdenum with the coadministration of celecoxib.
Study of ALXN1840 on the Metabolism of a CYP2B6 Substrate in Healthy Participants
Completed
Alexion Pharmaceuticals
Phase 1
This is a Phase 1, randomized, 2-period, 2-sequence, cross-over study designed to determine
the effect of ALXN1840 on the metabolism of bupropion, a sensitive cytochrome P450 2B6
(CYP2B6) substrate, in healthy male and female participants. The safety and tolerability of
ALXN1840 will be determined along with ALXN1840 pharmacokinetics (PK) in plasma as measured
via total molybdenum with the coadministration of bupropion.
A Study of the Cardiac Effects of ALXN1840 in Healthy Adults
Enrolling by invitation
ERT: Clinical Trial Technology Solutions
Phase 1
This study will evaluate the effect of a supratherapeutic dose of ALXN1840 on the heart rate
(HR)-corrected QT interval (QTc) in healthy adult participants. Moxifloxacin will be used as
the active control.
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