Adults 18 to 45, any sex, with Wilson Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Area Under The Plasma Concentration Versus Time Curve From Time 0 (Dosing) To The Last Quantifiable Concentration (AUCt) Of Plasma Total Molybdenum After Each DosePrimary· Day 1 through Day 11 of Dosing Periods 1 and 2
Dosing Period 1: ALXN1840 15 mg
Group
Value
95% CI
Cohort 1: Japanese Participants
10158.9753
± 1427.41833
Cohort 2: Non-Japanese Participants
9221.0132
± 3413.75213
Dosing Period 2: ALXN1840 60 mg
Group
Value
95% CI
Cohort 1: Japanese Participants
16178.7885
± 6103.53245
Cohort 2: Non-Japanese Participants
20911.3717
± 11491.5869
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline up to end of study visit (up to Day 29).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The main purpose of the study is to confirm how long ALXN1840 stays in the body of Japanese and non-Japanese healthy participants (that is, pharmacokinetic \[PK\] profile).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
NCT05047523 — Study of ALXN1840 Versus Standard of Care in Pediatric Participants With Wilson Disease
· Phase 3
· terminated
NCT04610580 — Bioavailability Study of 2 Oral Formulations of ALXN1840
· Phase 1
· completed
NCT04526210 — Study of ALXN1840 on the Metabolism of a CYP2B6 Substrate in Healthy Participants
· Phase 1
· completed
NCT04573309 — Copper and Molybdenum Balance in Participants With Wilson Disease Treated With ALXN1840
· Phase 2
· completed
NCT04560816 — A Study of the Cardiac Effects of ALXN1840 in Healthy Adults
· Phase 1
· completed
Other recruiting trials for Wilson Disease
Currently open trials in the same condition.
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· recruiting
NCT06430359 — Circadian Variation of Urinary Copper Excretion in Wilson Disease Patients
· recruiting
NCT06650319 — A Clinical Study to Evaluate the Safety and Efficacy of LY-M003 Injection in Patients With Wilson Disease
· EARLY_PHASE1
· recruiting
NCT06573723 — Institutional Registry of Rare Diseases
· recruiting
NCT03334292 — Natural History of Wilson Disease
· recruiting
Other Alexion Pharmaceuticals, Inc. trials
Trials by the same sponsor.
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· Phase 4
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NCT07352423 — Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ALXN2230 in Healthy Participants
· Phase 1
· recruiting
NCT07221838 — A Study to Investigate OCS Tapering in Adult Participants With Generalized Myasthenia Gravis Treated With Ravulizumab
· Phase 4
· recruiting
NCT07413250 — Assess Long-Term Safety of Danicopan Add-on Therapy in Participants With Paroxysmal Nocturnal Hemoglobinuria: Analysis o
· active not recruiting
NCT07308574 — Post-Marketing Clinical Study of Ravulizumab in Participants With Clinical aHUS
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· recruiting
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Alexion Pharmaceuticals, Inc.
Last refreshed: 7 November 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05641311.