EUCTR2020-005832-31-DK进行中（未招募）1 期
Efficacy of ALXN1840 on human hepatic copper uptake quantified with 64CuCl2 PET/CT-scan. - ALXN1840-HV-Cu Absorption
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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