First time in human study of oral anti-Serum Amyloid P (GSK3039294)
Research type
Research Study
Full title
A three-part open-label, non-randomised, dose-escalation study to investigate the safety and tolerability of GSK3039294 administered as a single dose to healthy volunteers, and as repeat dose to healthy volunteers and patients with systemic amyloidosis
IRAS ID
185396
Contact name
Disala Fernando
Contact email
Sponsor organisation
GSK Research & Development, Projects Clinical Platforms & Sciences
Eudract number
2015-003088-13
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 2 months, 3 days
Research summary
Systemic amyloidosis is a disease caused by the progressive build up of amyloid leading to organ failure and death. Amyloidosis is complex but always includes a protein called serum amyloid P (SAP). A drug which binds SAP in the bloodstream is being developed, but this is administered by injections. GlaxoSmithKline are developing a replacement (GSK3039294) which can be swallowed instead. \nThis study will assess the safety, tolerability and metabolism of GSK3039294 in humans and will determine whether enough active drug gets into the bloodstream to reduce SAP.\nThe study comprises 3 groups.\n Group A: 2 groups of approximately 6 healthy volunteers attend a screening visit, 2 in-patient sessions each lasting 5 days and one follow-up visit. Both treatment sessions involve swallowing one or more capsules containing drug, then blood sampling at multiple timepoints, urine analysis and heart monitoring. The interval between sessions is 5 – 13 days. The amount of drug given may be changed for each session.\nGroup B: approximately 6 – 12 healthy volunteers attend a screening visit, 3 in-patient sessions of 5 -6 days, an out-patient visit and one follow-up visit. Capsules will be taken daily for twenty-one days. During the first stay subjects will be fasted for part of one day. Monitoring will involve similar procedures as in Group A. \nGroup C: approximately 12 patients with systemic amyloidosis attend a screening visit and then take capsules daily for 21 days. They will stay in the clinic for the first 9 days followed by outpatient visits for regular assessments every 3 – 4 days. The procedures will be similar to those for Group A. After 21 days patients will attend weekly follow-up visits for further 42 days.\nTaking part in the study will not have direct benefit to participants. \n
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
16/SC/0009
Date of REC Opinion
5 Apr 2016
REC opinion
Further Information Favourable Opinion