Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04573309 | Copper and Molybdenum Balance in Participants With Wilson Disease Treated With ALXN1840 | PHASE2 | COMPLETED | 9 | — | — | Sep 7, 2020 | Jun 7, 2022 | Jun 24, 2024 | 3 | United States, New Zealand +1 |
| NCT02273596 | Efficacy and Safety Study of WTX101 (ALXN1840) in Adult Wilson Disease Patients | PHASE2 | COMPLETED | 29 | — | — | Nov 24, 2014 | Nov 7, 2018 | Sep 29, 2021 | 9 | United States, Austria +3 |
| NCT04526210 | Study of ALXN1840 on the Metabolism of a CYP2B6 Substrate in Healthy Participants | PHASE1 | COMPLETED | 54 | — | — | Oct 21, 2020 | May 28, 2021 | Aug 31, 2023 | 1 | United States |
| NCT04526197 | Phase 1 Study of ALXN1840 on the Metabolism of a CYP2C9 Substrate in Healthy Participants. | PHASE1 | COMPLETED | 36 | — | — | Jul 7, 2020 | Nov 3, 2020 | Aug 21, 2023 | 1 | United States |
| NCT05641311 | Pharmacokinetic Study of Oral ALXN1840 in Japanese and Non-Japanese Adult Healthy Participants | PHASE1 | COMPLETED | 24 | — | — | Feb 20, 2019 | May 2, 2019 | Nov 7, 2023 | 1 | United Kingdom |
Copper balance is defined as the difference between the measured copper input in food and drink, and the measured copper elimination in urine and feces, and was calculated as the average daily copper balance over the collection period.
Copper balance is defined as the difference between the measured copper input in food and drink, and the measured copper elimination in urine and feces, and was calculated as the average daily copper balance over the collection period.
Copper balance is defined as the difference between the measured copper input in food and drink, and the measured copper elimination in urine and feces, and was calculated as the average daily copper balance over the collection period.
Copper balance is defined as the difference between the measured copper input in food and drink, and the measured copper elimination in urine and feces, and was calculated as the average daily copper balance over the collection period.
Normalized concentrations of NCC was defined as who achieving or maintaining normalized levels of NCC (0.8 to 2.3 micromole \[μmol\]l/liter \[L\]\]) adjusted for Mo plasma concentration or reaching a reduction of at least 25% in NCC corrected for Mo if above the normal reference range at the time of enrollment. NCC was calculated by subtracting the amount of copper (Cu) bound to ceruloplasmin (CP) from the total plasma Cu concentration. Post-baseline NCC values were adjusted (corrected) to account for Cu bound in tripartite complexes with ALXN1840 and albumin. Descriptive statistics are reported.
Blood samples were collected for pharmacokinetics (PK) analysis of celecoxib. Cmax is reported as nanograms (ng)/milliliter (mL).
Blood samples were collected for pharmacokinetic (PK) analysis of celecoxib. Area Under The Plasma Concentration Versus Time Curve From Time 0 To The Last Quantifiable Concentration (AUCt) is reported as hours•ng/mL (h•ng/mL).
Blood samples were collected for pharmacokinetic (PK) analysis of celecoxib. Area Under The Plasma Concentration Versus Time Curve From Time 0 To Infinity (AUCinf) is reported as h•ng/mL.
| Arm | Type | Description |
|---|---|---|
| ALXN1840 | EXPERIMENTAL | Participants will be administered ALXN1840 at a dose of 15 milligrams (mg)/day on Day 1 through Day 28 and then increased to 30 mg/day on Day 29 through Day 39 |
| Treatment A | EXPERIMENTAL | Participants will receive bupropion. |
| Treatment B | EXPERIMENTAL | Participants will receive bupropion with ALXN1840. |
| Treatment Sequence A-B | EXPERIMENTAL | Participants received 1 treatment during each study period in the following sequence: * Treatment A: Celecoxib. * Treatment B: Celecoxib plus ALXN1840. |
| Treatment Sequence B-A | EXPERIMENTAL | Participants received 1 treatment during each study period in the following sequence: * Treatment B: Celecoxib plus ALXN1840. * Treatment A: Celecoxib. |
| Cohort 1: Japanese Participants | EXPERIMENTAL | All Japanese participants will receive a single dose of ALXN1840 15 milligrams (mg) in Dosing Period 1 and will receive a single dose of ALXN1840 60 mg in Dosing Period 2. |
| Cohort 2: Non-Japanese Participants | EXPERIMENTAL | All non-Japanese participants will receive a single dose of ALXN1840 15 mg in Dosing Period 1 and will receive a single dose of ALXN1840 60 mg in Dosing Period 2. |
| Name | Type | Description |
|---|---|---|
| ALXN1840 | DRUG | Administered orally as tablets. |
| Bupropion Hydrochloride | DRUG | Bupropion hydrochloride will be administered orally as a single dose as one 150 milligrams (mg) tablet with 240 milliliters of water (fasting). |
| Celecoxib | DRUG | Celecoxib was administered orally as a single dose as one 200-mg tablet with 240 mL of water (fasting). |
Inclusion Criteria: 1. Diagnosis of WD by Leipzig Criteria ≥ 4. 2. Able to reside in the clinical research unit for intensive metabolic monitoring of copper and molybdenum. 3. Participants willing to adhere to copper/molybdenum-controlled diet during the study. 4. Willing and able to follow protoco...