NCT02953808

A Single Centre, Double-blind, Randomised, Placebo-controlled, and Single Dose-ascending Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics, of Single Intravenous Doses of GSK2315698 in Healthy Japanese Subjects

Completed Phase 1 Last updated 18 January 2017

What this trial tests

Phase 1 trial testing Placebo in Amyloidosis in 18 participants. Completed in 1 December 2016.

Timeline

1 November 2016

Primary endpoint
1 December 2016

1 December 2016

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	18
Start date	1 November 2016
Primary completion	1 December 2016
Estimated completion	1 December 2016
Sites	1 location across Japan

Drugs / interventions tested

• Placebo
• GSK2315698 — full drug profile →

Conditions studied

• Amyloidosis — all drugs for Amyloidosis →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 20 to 64, male only, with Amyloidosis. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of subjects with adverse events (AE) and serious adverse events (SAE)
  Time frame: Over a maximum period of approximately 29 days
• Number of subjects with abnormalities in clinical laboratory parameters
  Time frame: Over a maximum period of approximately 59 days
  Abnormalities will be assessed in laboratory parameters of hematology, clinical chemistry, and routine urinalysis.
• Number of subjects with abnormalities in vital sign parameters
  Time frame: Over a maximum period of approximately 59 days
  Abnormalities will be assessed in the vital signs of respiratory rate, pulse rate, blood pressure, and body temperature. Vital signs will be measured in a supine position after 5 minutes of rest.
• Number of subjects with electrocardiogram (ECG) abnormalities
  Time frame: Over a maximum period of approximately 59 days
  Single 12-lead ECG will be obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval corrected for heart rate by Fridericia's formula (QTcF) intervals.
• Plasma concentration of GSK2315698
  Time frame: Pre-dose and 0.25, 1, 2, 4, 6, 8, 12, 24 hours post-dose in Cohort 1; Day 1 (pre-dose and 0.25, 1, 4, 12, 15, 18, 24 hours post-dose), and Days 5, 8, 14 in Cohort 2
  Whole blood samples of approximately 2 milliliters (mL) will be collected for measurement of plasma concentrations of GSK2315698.
• Maximum observed plasma concentration (Cmax) of GSK2315698
  Time frame: Pre-dose and 0.25, 1, 2, 4, 6, 8, 12, 24 hours post-dose in Cohort 1; Day 1 (pre-dose and 0.25, 1, 4, 12, 15, 18, 24 hours post-dose), and Days 5, 8, 14 in Cohort 2
  Cmax will be calculated if data permit.

Sponsor's own description

This is the first study in which GSK2315698 will be administered in Japanese population. The primary objective of the study is to investigate safety and tolerability, pharmacokinetics, and pharmacodynamics after single intravenous infusion in healthy subjects. This will be a single center, double-blind, randomized, placebo-controlled, dose-ascending study.

Subjects in Cohort 1 will attend 3 dosing sessions, and will be randomized to one of the 3 groups. Each group will receive GSK2315698 and Placebo in a defined sequence. The dose levels of GSK2315698 are set to 10 milligrams (mg) per hour (hr), 20 mg/hr, and 40 mg/hr, to be administered over 1 hour. Dosing sessions 1 and 2, and dosing sessions 2 and 3, will be separated by a washout period of at least 8 and 10 days, respectively.

Subjects in Cohort 2 will attend a single dosing session, and will be randomized to receive either GSK2315698 20 mg/hr or Placebo, over a period of 15 hours.

A sufficient number of subjects will be randomized such that 18 subjects (9 in each cohort) complete the study. The duration of participation for any subject in this study will be approximately 59 days.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Targeting Amyloid Fibrils by Passive Immunotherapy in Systemic Amyloidosis.
   Nuvolone M, Nevone A, Merlini G. · · 2022 · cited 23× · PMID 36094752 · DOI 10.1007/s40259-022-00550-w