PK Study of Oral ALXN1840 at 2 Dose Strengths in Healthy Adult Subject
Research type
Research Study
Full title
A Phase 1, Randomized, Open-Label, 2 Way Crossover Study to Assess the Single-Dose Pharmacokinetics of ALXN1840 Enteric Coated Tablets at 2 Dose Strengths in Healthy Adult Subjects
IRAS ID
261207
Contact name
Ulrike Lorch
Contact email
Sponsor organisation
Alexion Pharma GmbH
Eudract number
2019-000516-28
Duration of Study in the UK
0 years, 3 months, 8 days
Research summary
We are conducting a clinical trial with the investigational drug bis-choline tetrathiomolybdate (ALXN1840). Alexion Pharmaceuticals, Inc. are developing this for the treatment of Wilson’s Disease (WD). This study will assess the pharmacokinetics and safety of ALXN1840 at two dose strengths in healthy adult volunteers. The bioavailability of three 5mg enteric-coated (EC) tablets will be compared with that of one 15mg EC tablet.\n\nThe 15mg formulation is currently being tested in an on-going Phase 3 Study - WTX101-301. The novel 5mg formulation has not been tested in humans. It has been manufactured for paediatric use.\n\nWD is a genetic disorder causing higher levels of copper in the body than normal. Increased copper levels can be toxic and cause damage to the liver, brain and other organs. Currently there are few treatment options available for WD.\n\nALXN1840 is a novel first-in-class protein binding agent that forms virtually irreversible, stable copper-protein complexes. These are then removed by biliary excretion into faeces. It also acts directly on the liver to remove excess copper. It is hoped that ALXN1840 will yield greater compliance compared to current treatments, as it is administered once daily rather than multiple times daily.\n\nALXN1840 has been evaluated in 28 WD patients, where monotherapy reduced mean serum copper by 72% compared to baseline. Liver status also improved in most patients. ALXN1840 was generally well tolerated.\n\n48 volunteers will participate, in 2 sequences, each lasting at least 70 days (27 days for screening, 29 days for dosing periods and following up, with at least 14 days between two dosing periods). Both sequences will receive one 15mg EC ALXN1840 tablet in one period and three 5mg EC ALXN1840 tablets in the other period.\n\nWe will assess safety parameters including physical examination, vital signs, laboratory evaluations, electrocardiogram and monitoring of adverse events.\n
REC name
London - London Bridge Research Ethics Committee
REC reference
19/LO/0320
Date of REC Opinion
5 Jun 2019
REC opinion
Favourable Opinion