Healthy Volunteers (Wilson's disease) MedDRA version: 22.0 Level: SOC Classification code 10022891 Term: Investigations System Organ Class: 10022891 - Investigations
Conditions
Interventions
Trade Name: Cuprior 150 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: TRIENTINE DIHYDROCHLORIDE
CAS Number: 38260-01-4
Other descriptive name: Cuprior
Concentration unit: mg milligram(s)
Concent
Sponsors
Alexion Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age above 18 2. BMI =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Participation in a medical trial including a PET scan during the past year 2. Known hypersensitivity for 64-Cu, copper in general or one of the other ingredients in the tracer formula 3. Assessed ineligibility by medical doctor on basis of blood parameters measured at inclusion, if these are abnormal. 4. Participants with known contraindications for any of the trial medications: a. ALXN1840: No known. b. Metalcaptase: Hypersensitivity to the active ingredient or excipients (Calcium behenate, calcium hydrogen phosphate-dihydrate, cellulose (microcrystalline and powder), copovidon, dimeticon, macrogel 6000, cornstarch, poly (methacrylic acid-co-methyl-methacrylate) (1:1), triacetin, methacrylic acid-ethylacrylate-copolymer (1:1), polysorbate 80, hydrogenated castor oil, highly disperse siliconoxide, talc, titaniumoxide), Penicillin allergy, renal injuries, bone marrow disorders, systemic lupus erythematodes, high titre of antinuclear antibodies, parenchymal liver disorders or simultaneous gold or chloroquine therapy. c. Cuprior: Hypersensitivity to the active ingredient or excipients (Mannitol, koloid water-free silica, glyceryldibenat). 5. Claustrophobia 6. Pregnancy, breastfeeding or the desire to become pregnant before the trial is terminated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of ALXN1840 on hepatic copper uptake in healthy participants, compared to the effect of penicillamine, trientine and placebo.;Secondary Objective: • To investigate the effect of ALXN1840 on copper uptake in the gallbladder, pancreas, kidney, small and large intestines and heart compared to the effect of penicillamine, trientine and placebo. • To investigate ALXN1840’s effect on metallothionein levels compared to the effect of penicillamine, trientine and placebo. ;Primary end point(s): 1. A comparison of mean hepatic standard uptake value (SUV) between the three groups vs. placebo before and after intervention ;Timepoint(s) of evaluation of this end point: Second half of 2021. Patient health will be monitored. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Comparison of mean SUV’s in other organs of interest (small intestine, colon, kidney, gall bladder, pancreas, heart) between the three groups vs. placebo before and after intervention 2. Comparison of leukocyte MT expression between the three groups vs. placebo before and after the intervention. ;Timepoint(s) of evaluation of this end point: Second half of 2021 | — |
Countries
Denmark
Contacts
Public ContactPublic information about the trial.
Aarhus University Hospital
Outcome results
None listed