NCT03567499

Pro-arrhythmic Potential of GSK3039294 in Healthy Subjects

A Randomised, Double-blind, Placebo Controlled, Repeat-dose, Cross-over Phase I Study to Evaluate the Pro-arrhythmic Potential of GSK3039294 in Healthy Participants

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Amyloidosis

Interventions

Type	Name	Description
DRUG	GSK3039294	GSK3039294 capsules will be available with a dose strength of 100 mg and 200 mg to be taken as single or multiple capsules orally along with water depending on the dosage required.
DRUG	Placebo	Matching placebo capsules to match active 100 mg and 200 mg dose strength will be available and to be taken as single or multiple capsules orally along with water depending on the number of active capsules to blind.

Timeline

• Start date: 2018-07-12
• Primary completion: 2019-05-03
• Completion: 2019-05-03
• First posted: 2018-06-25
• Last updated: 2018-10-09

Locations

1 site across 1 country: United Kingdom