Pro-arrhythmic Potential of GSK3039294 in Healthy Subjects
Status:
Withdrawn
Trial end date:
2019-05-03
Target enrollment:
Participant gender:
Summary
GSK3039294 has been developed to offer an orally available alternative to parenteral
GSK2315698 (miridesap) for plasma serum amyloid P component (SAP) depletion prior to and
following use of anti-SAP Monoclonal Antibody (mAb) in the treatment of systemic amyloidosis.
The primary objectives of the study are to assess the cardiac arrhythmic potential of
GSK3039294 and evaluate safety and tolerability of repeat doses of GSK3039294, in healthy
subjects relative to placebo for the same duration. This study will consist of two parts,
Part A and a conditional Part B. Part A is designed as a randomized double-blinded, 3 period,
placebo-controlled, repeat-dose, crossover study. The decision to initiate Part B will be
based on an evaluation of data from Part A, which will include an overall assessment of
safety, pharmacokinetics (PK) and pharmacodynamics (PD). In Part A, there will be three
treatment periods with 7 days of dosing in each and minimum 7-day washout period between each
treatment session. Each subject will receive two dose levels of GSK3039294 and placebo. In
Part B, there will be two treatment periods with 7 days of dosing in each and minimum 7-day
washout period. Each subject will receive one dose level of GSK3039294 and placebo. In Part
A, approximately 48 subjects will be recruited for an estimated total of 36 completers. In
Part B, approximately 32 subjects will be recruited for an estimated total of 24 completers.
The study will last up to approximately 10 weeks from screening to follow-up.