The effect of ALXN1840 on uptake of copper in the liver as measured by copper PET/CT scan.

Phase 1

• Conditions: Healthy Volunteers (Wilson's disease); MedDRA version: 22.0Level: SOCClassification code 10022891Term: InvestigationsSystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2020-005832-31-DK
• Lead Sponsor: Alexion Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-01
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1.Age above 18
2.BMI < 30
3.Fertile women must accept to apply contraception at the time of the first PET-scan until 1 month after the last PET-scan: Spiral or hormonal contraception (contraceptive pill, implantation, transdermal patch, vaginal ring or depot injection)
4.At the day of the tracer administration, a negative pregnancy test for fertile women must be available. Pregnancy test will be performed as a blood test.
5.At the day of the tracer administration, a signed informed consent must be available

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 32
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified