Effects of GSK3039294 on heart rhythm in healthy participants v1
Research type
Research Study
Full title
A randomised, double-blind, placebo controlled, repeat-dose, cross-over, Phase I study to evaluate the pro-arrhythmic potential of GSK3039294 in healthy participants (18-001)
IRAS ID
248213
Contact name
Adeep Puri
Contact email
Sponsor organisation
GlaxoSmithKline (GSK)
Eudract number
2017-004808-21
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
GSK3039294 is broken down in the body to an active medicine, called miridesap, which is part of an experimental new combination treatment for systemic amyloidosis (SA). SA is caused by abnormal proteins clumping together; forming ‘amyloid deposits’ in organs including the kidney, liver, heart and spleen, which can eventually lead to organ failure. A key part of amyloid deposits is a protein called serum amyloid P (SAP). Miridesap removes SAP from the bloodstream, then the second part of the combination treatment (an antibody) attaches to SAP in amyloid deposits; helping the immune system to clear them.
Miridesap is currently given by injection. Sometimes people get side effects in the areas where injections are given. GSK3039294 can be taken by mouth, so we hope it will reduce the number of injections needed by SA patients and have fewer side effects.
We’ll test repeated doses of GSK3039294 in up to 80 healthy volunteers, aged 18–65 years, to find out if it affects heart rhythm, has any other important side effects and its blood levels.
The study will be in 2 parts, with multiple study sessions in each part. In each study session, participants will take doses of GSK3039294 or placebo for 7 days, as follows:*Part A – up to 48 participants will attend 3 study sessions, taking GSK3039294 in 2 sessions and placebo in 1 session.
*Part B – up to 32 participants will attend 2 study sessions, taking GSK3039294 in 1 session and placebo in 1 session.
Participants will take up to 10 weeks to finish the study. Each participant will have: 2 screening visits; 2 short outpatient visits and an 8-night ward stay in each study session; and a final follow-up visit.
A pharmaceutical company GlaxoSmithKline is funding the study.
The study will take place at 1 centre in London.
REC name
HSC REC B
REC reference
18/NI/0107
Date of REC Opinion
21 Jun 2018
REC opinion
Favourable Opinion