NCT03567499

Pro-arrhythmic Potential of GSK3039294 in Healthy Subjects

Withdrawn Phase 1 Last updated 9 October 2018

What this trial tests

Phase 1 trial testing GSK3039294 in Amyloidosis. Withdrawn.

Timeline

12 July 2018

Primary endpoint
3 May 2019

3 May 2019

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Start date	12 July 2018
Primary completion	3 May 2019
Estimated completion	3 May 2019
Sites	1 location across United Kingdom

Drugs / interventions tested

• GSK3039294 — full drug profile →
• Placebo

Conditions studied

• Amyloidosis — all drugs for Amyloidosis →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 65, any sex, with Amyloidosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.