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NCT02603172 · OUTCOME

Part B: Mean Change From Baseline in 12-lead ECG

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
MEAN
Unit
Millisecond
Interval / dispersion
Standard Deviation
Time frame
Cohort 3: Baseline (pre-dose), Day 1 (1 hour), Days 2, 3, 4, 5, 6, 7 (pre-dose and 1 hour), 8 and 21; Cohort 4: Up to Day 35

What was measured

Triplicate ECG was measured in semi-supine position after 5 minutes rest. A single 12-lead ECG was measured by using ECG machine that automatically measured PR, QRS, QT, and QTcF intervals. Baseline is defined as the latest available assessment pre the first dose of study drug in Part B. Change from Baseline was calculated as any visit post Baseline value minus Baseline value.

Analysis population: Safety population. Data was not collected as study was terminated, due to safety reasons during conduct of Part B (end of Cohort 3) whereas Cohort 4a and 4b were not recruited in Part B.

Groups in this outcome

Part B: Cohort 3- GSK3039294 600 mg QD

Participants received GSK3039294 600 mg, capsules, orally, under fed condition, QD for 7 days in cohort 3.

Part B: Cohort 4a- GSK3039294

Participants were planned to receive repeat dose of GSK3039294 for 21 days in cohort 4a. The dose level was to be adjusted once during the 21 days. Cohort 4a was not initiated due to safety reasons during conduct of Part B (Cohort 3).

Part B: Cohort 4b- GSK3039294

Participants were planned to receive repeat dose of GSK3039294 for 21 days in cohort 4b. The dose level was to be adjusted once during the 21 days. Cohort 4b was not initiated due to safety reasons during conduct of Part B (Cohort 3).

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 B: Cohort 3- GSK3039294 600 mg QD8
Part B: Cohort 4a- GSK30392940
Part B: Cohort 4b- GSK30392940

Reported measurements

PR interval- Day 1: 1 hour
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD3.42.42Not reportedNot reportedNot reported
PR interval- Day 2: pre-dose
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD2.810.57Not reportedNot reportedNot reported
PR interval- Day 2: 1 hour
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD5.37.73Not reportedNot reportedNot reported
PR interval- Day 3: pre-dose
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD5.08.05Not reportedNot reportedNot reported
PR interval- Day 3: 1 hour
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD6.12.96Not reportedNot reportedNot reported
PR interval- Day 4: pre-dose
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD2.98.21Not reportedNot reportedNot reported
PR interval- Day 4: 1 hour
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD6.54.48Not reportedNot reportedNot reported
PR interval- Day 5: pre-dose
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD4.56.17Not reportedNot reportedNot reported
PR interval- Day 5: 1 hour
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD2.99.50Not reportedNot reportedNot reported
PR interval- Day 6: pre-dose
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD4.07.57Not reportedNot reportedNot reported
PR interval- Day 6: 1 hour
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD6.86.96Not reportedNot reportedNot reported
PR interval- Day 7: pre-dose
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD4.67.26Not reportedNot reportedNot reported
PR interval- Day 7: 1 hour
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD6.17.13Not reportedNot reportedNot reported
PR interval- Day 8
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD7.37.34Not reportedNot reportedNot reported
PR interval- Day 21
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD2.58.38Not reportedNot reportedNot reported
QRS duration- Day 1: 1 hour
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD-0.11.78Not reportedNot reportedNot reported
QRS duration- Day 2: pre-dose
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD-1.34.22Not reportedNot reportedNot reported
QRS duration- Day 2: 1 hour
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD-1.35.95Not reportedNot reportedNot reported
QRS duration- Day 3: pre-dose
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD-1.53.29Not reportedNot reportedNot reported
QRS duration- Day 3: 1 hour
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD-0.23.42Not reportedNot reportedNot reported
QRS duration- Day 4: pre-dose
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD1.813.09Not reportedNot reportedNot reported
QRS duration- Day 4: 1 hour
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD-1.14.20Not reportedNot reportedNot reported
QRS duration- Day 5: pre-dose
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD-1.45.20Not reportedNot reportedNot reported
QRS duration- Day 5: 1 hour
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD0.62.97Not reportedNot reportedNot reported
QRS duration- Day 6: pre-dose
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD-1.23.41Not reportedNot reportedNot reported
QRS duration- Day 6: 1 hour
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD-0.53.08Not reportedNot reportedNot reported
QRS duration- Day 7: pre-dose
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD-1.55.25Not reportedNot reportedNot reported
QRS duration- Day 7: 1 hour
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD1.14.22Not reportedNot reportedNot reported
QRS duration- Day 8
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD-0.95.61Not reportedNot reportedNot reported
QRS duration- Day 21
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD-1.56.16Not reportedNot reportedNot reported
QT interval- Day 1: 1 hour
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD6.07.47Not reportedNot reportedNot reported
QT interval- Day 2: pre-dose
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD5.97.44Not reportedNot reportedNot reported
QT interval- Day 2: 1 hour
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD7.27.44Not reportedNot reportedNot reported
QT interval- Day 3: pre-dose
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD1.58.11Not reportedNot reportedNot reported
QT interval- Day 3: 1 hour
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD1.012.78Not reportedNot reportedNot reported
QT interval- Day 4: pre-dose
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD2.99.68Not reportedNot reportedNot reported
QT interval- Day 4: 1 hour
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD0.410.60Not reportedNot reportedNot reported
QT interval- Day 5: pre-dose
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD1.27.30Not reportedNot reportedNot reported
QT interval- Day 5: 1 hour
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD16.616.04Not reportedNot reportedNot reported
QT interval- Day 6: pre-dose
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD7.78.64Not reportedNot reportedNot reported
QT interval- Day 6: 1 hour
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD2.06.12Not reportedNot reportedNot reported
QT interval- Day 7: pre-dose
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD2.611.46Not reportedNot reportedNot reported
QT interval- Day 7: 1 hour
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD2.512.02Not reportedNot reportedNot reported
QT interval- Day 8
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD1.78.21Not reportedNot reportedNot reported
QT interval- Day 21
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD1.412.59Not reportedNot reportedNot reported
QTcF interval- Day 1: 1 hour
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD1.15.77Not reportedNot reportedNot reported
QTcF interval- Day 2: pre-dose
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD4.35.00Not reportedNot reportedNot reported
QTcF interval- Day 2: 1 hour
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD2.74.13Not reportedNot reportedNot reported
QTcF interval- Day 3: pre-dose
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD0.53.80Not reportedNot reportedNot reported
QTcF interval- Day 3: 1 hour
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD0.15.71Not reportedNot reportedNot reported
QTcF interval- Day 4: pre-dose
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD-1.35.49Not reportedNot reportedNot reported
QTcF interval- Day 4: 1 hour
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD-3.84.73Not reportedNot reportedNot reported
QTcF interval- Day 5: pre-dose
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD-0.45.82Not reportedNot reportedNot reported
QTcF interval- Day 5: 1 hour
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD2.310.37Not reportedNot reportedNot reported
QTcF interval- Day 6: pre-dose
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD-2.66.92Not reportedNot reportedNot reported
QTcF interval- Day 6: 1 hour
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD-1.06.76Not reportedNot reportedNot reported
QTcF interval- Day 7: pre-dose
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD2.45.12Not reportedNot reportedNot reported
QTcF interval- Day 7: 1 hour
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD0.93.49Not reportedNot reportedNot reported
QTcF interval- Day 8
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD0.76.70Not reportedNot reportedNot reported
QTcF interval- Day 21
Values in Millisecond · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD7.16.59Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.42
        value
        3.4
    title
    PR interval- Day 1: 1 hour
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.57
        value
        2.8
    title
    PR interval- Day 2: pre-dose
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.73
        value
        5.3
    title
    PR interval- Day 2: 1 hour
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.05
        value
        5.0
    title
    PR interval- Day 3: pre-dose
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.96
        value
        6.1
    title
    PR interval- Day 3: 1 hour
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.21
        value
        2.9
    title
    PR interval- Day 4: pre-dose
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.48
        value
        6.5
    title
    PR interval- Day 4: 1 hour
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.17
        value
        4.5
    title
    PR interval- Day 5: pre-dose
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.50
        value
        2.9
    title
    PR interval- Day 5: 1 hour
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.57
        value
        4.0
    title
    PR interval- Day 6: pre-dose
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.96
        value
        6.8
    title
    PR interval- Day 6: 1 hour
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.26
        value
        4.6
    title
    PR interval- Day 7: pre-dose
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    units
    Participants
description
Triplicate ECG was measured in semi-supine position after 5 minutes rest. A single 12-lead ECG was measured by using ECG machine that automatically measured PR, QRS, QT, and QTcF intervals. Baseline is defined as the latest available assessment pre the first dose of study drug in Part B. Change from Baseline was calculated as any visit post Baseline value minus Baseline value.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received GSK3039294 600 mg, capsules, orally, under fed condition, QD for 7 days in cohort 3.
    id
    OG000
    title
    Part B: Cohort 3- GSK3039294 600 mg QD
  2. description
    Participants were planned to receive repeat dose of GSK3039294 for 21 days in cohort 4a. The dose level was to be adjusted once during the 21 days. Cohort 4a was not initiated due to safety reasons during conduct of Part B (Cohort 3).
    id
    OG001
    title
    Part B: Cohort 4a- GSK3039294
  3. description
    Participants were planned to receive repeat dose of GSK3039294 for 21 days in cohort 4b. The dose level was to be adjusted once during the 21 days. Cohort 4b was not initiated due to safety reasons during conduct of Part B (Cohort 3).
    id
    OG002
    title
    Part B: Cohort 4b- GSK3039294
param Type
MEAN
population Description
Safety population. Data was not collected as study was terminated, due to safety reasons during conduct of Part B (end of Cohort 3) whereas Cohort 4a and 4b were not recruited in Part B.
reporting Status
POSTED
time Frame
Cohort 3: Baseline (pre-dose), Day 1 (1 hour), Days 2, 3, 4, 5, 6, 7 (pre-dose and 1 hour), 8 and 21; Cohort 4: Up to Day 35
title
Part B: Mean Change From Baseline in 12-lead ECG
type
PRIMARY
unit Of Measure
Millisecond

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Preserved source evidence · Not medical advice