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NCT02603172 · OUTCOME

Part C: AUC(0-inf) of GSK3039294 and GSK2315698

A Safety Study of GSK3039294 in Healthy Volunteers and Patients With Systemic Amyloidosis · Source last updated 2019-09-23

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Day 1 (pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose); Day 2 to 20 (pre-dose); Day 21 (pre-dose, and 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post-dose; Week 4 and 5

What was measured

This analysis was planned but not performed for Part C as the study was terminated early during Part B.

Analysis population: PK population. Data was not collected as study was terminated due to safety reasons during conduct of Part B (end of Cohort 3) whereas Part C was not initiated.

Groups in this outcome

Part C: GSK3039294

Participants were planned to receive repeat dosing of GSK3039294 at the predicted optimal clinical dose determined from Part B for a total of 21 days.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Part C: GSK30392940

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    units
    Participants
description
This analysis was planned but not performed for Part C as the study was terminated early during Part B.
groups
  1. description
    Participants were planned to receive repeat dosing of GSK3039294 at the predicted optimal clinical dose determined from Part B for a total of 21 days.
    id
    OG000
    title
    Part C: GSK3039294
population Description
PK population. Data was not collected as study was terminated due to safety reasons during conduct of Part B (end of Cohort 3) whereas Part C was not initiated.
reporting Status
POSTED
time Frame
Day 1 (pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose); Day 2 to 20 (pre-dose); Day 21 (pre-dose, and 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post-dose; Week 4 and 5
title
Part C: AUC(0-inf) of GSK3039294 and GSK2315698
type
SECONDARY

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice