Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02603172 · OUTCOME

Part B: Mean Change From Baseline in Heart Rate by 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
Beats per minute
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 min rest. A single 12-lead ECG was measured by using ECG machine that automatically measures heart rate. Baseline is defined as the latest available assessment pre the first dose of study drug within each period 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

Day 1: 1 hour
Values in Beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD-1.93.92Not reportedNot reportedNot reported
Day 2: pre-dose
Values in Beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD-0.64.27Not reportedNot reportedNot reported
Day 2: 1 hour
Values in Beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD-2.13.94Not reportedNot reportedNot reported
Day 3: pre-dose
Values in Beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD1.34.84Not reportedNot reportedNot reported
Day 3: 1 hour
Values in Beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD-0.44.72Not reportedNot reportedNot reported
Day 4: pre-dose
Values in Beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD0.94.20Not reportedNot reportedNot reported
Day 4: 1 hour
Values in Beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD-1.73.65Not reportedNot reportedNot reported
Day 5: pre-dose
Values in Beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD-0.63.97Not reportedNot reportedNot reported
Day 5: 1 hour
Values in Beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD9.96.62Not reportedNot reportedNot reported
Day 6: pre-dose
Values in Beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD2.44.59Not reportedNot reportedNot reported
Day 6: 1 hour
Values in Beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD-1.04.78Not reportedNot reportedNot reported
Day 7: pre-dose
Values in Beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD-0.05.14Not reportedNot reportedNot reported
Day 7: 1 hour
Values in Beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD-0.65.92Not reportedNot reportedNot reported
Day 8
Values in Beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD1.55.24Not reportedNot reportedNot reported
Day 21
Values in Beats per minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD3.48.59Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.92
        value
        -1.9
    title
    Day 1: 1 hour
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.27
        value
        -0.6
    title
    Day 2: pre-dose
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.94
        value
        -2.1
    title
    Day 2: 1 hour
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.84
        value
        1.3
    title
    Day 3: pre-dose
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.72
        value
        -0.4
    title
    Day 3: 1 hour
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.20
        value
        0.9
    title
    Day 4: pre-dose
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.65
        value
        -1.7
    title
    Day 4: 1 hour
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.97
        value
        -0.6
    title
    Day 5: pre-dose
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.62
        value
        9.9
    title
    Day 5: 1 hour
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.59
        value
        2.4
    title
    Day 6: pre-dose
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.78
        value
        -1.0
    title
    Day 6: 1 hour
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.14
        value
        -0.0
    title
    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 min rest. A single 12-lead ECG was measured by using ECG machine that automatically measures heart rate. Baseline is defined as the latest available assessment pre the first dose of study drug within each period 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 Heart Rate by 12-lead ECG
type
PRIMARY
unit Of Measure
Beats per minute

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

Preserved source evidence · Not medical advice