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NCT02603172 · OUTCOME

Part B: Plasma Serum Amyloid P Component (SAP) Level of GSK3039294

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
ng/mL
Interval / dispersion
Standard Deviation
Time frame
Cohort 3:Days1(pre-dose, 2hour post-dose),2(pre-dose),4(pre-dose),5(pre-dose, 30min,1,2,3,4,6 hours post-dose),7(pre-dose)and 21post-dose;Cohort4:Days1(pre-dose, 2 hour post-dose),2(pre-dose),4(pre-dose), 5(pre-dose, and 2 hours post-dose) and 35post-dose

What was measured

Blood samples were collected at specified time points for GSK3039294. Pharmacodynamic (PD) population consist of all participants who received at least one dose of study medication and who also had a baseline measurement and at least one post-treatment PD measure.

Analysis population: PD 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. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

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: pre-dose (n=8, 0, 0)

Analysis denominator · Participants

GroupSource count
Part B: Cohort 3- GSK3039294 600 mg QD8
Part B: Cohort 4a- GSK30392940
Part B: Cohort 4b- GSK30392940
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD32318.696403.13Not reportedNot reportedNot reported
Day 1: 2 hour (n=8, 0, 0)

Analysis denominator · Participants

GroupSource count
Part B: Cohort 3- GSK3039294 600 mg QD8
Part B: Cohort 4a- GSK30392940
Part B: Cohort 4b- GSK30392940
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD4064.37761.37Not reportedNot reportedNot reported
Day 2: pre-dose (n=8, 0, 0)

Analysis denominator · Participants

GroupSource count
Part B: Cohort 3- GSK3039294 600 mg QD8
Part B: Cohort 4a- GSK30392940
Part B: Cohort 4b- GSK30392940
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD939.83555.71Not reportedNot reportedNot reported
Day 4: pre-dose (n=7, 0, 0)

Analysis denominator · Participants

GroupSource count
Part B: Cohort 3- GSK3039294 600 mg QD7
Part B: Cohort 4a- GSK30392940
Part B: Cohort 4b- GSK30392940
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD526.49303.64Not reportedNot reportedNot reported
Day 5: pre-dose (n=8, 0, 0)

Analysis denominator · Participants

GroupSource count
Part B: Cohort 3- GSK3039294 600 mg QD8
Part B: Cohort 4a- GSK30392940
Part B: Cohort 4b- GSK30392940
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD456.28173.19Not reportedNot reportedNot reported
Day 5: 30 min (n=7, 0, 0)

Analysis denominator · Participants

GroupSource count
Part B: Cohort 3- GSK3039294 600 mg QD7
Part B: Cohort 4a- GSK30392940
Part B: Cohort 4b- GSK30392940
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD506.16232.88Not reportedNot reportedNot reported
Day 5: 1 hour (n=8, 0, 0)

Analysis denominator · Participants

GroupSource count
Part B: Cohort 3- GSK3039294 600 mg QD8
Part B: Cohort 4a- GSK30392940
Part B: Cohort 4b- GSK30392940
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD458.72174.85Not reportedNot reportedNot reported
Day 5: 2 hour (n=7, 0, 0)

Analysis denominator · Participants

GroupSource count
Part B: Cohort 3- GSK3039294 600 mg QD7
Part B: Cohort 4a- GSK30392940
Part B: Cohort 4b- GSK30392940
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD449.03160.56Not reportedNot reportedNot reported
Day 5: 3 hour (n=8, 0, 0)

Analysis denominator · Participants

GroupSource count
Part B: Cohort 3- GSK3039294 600 mg QD8
Part B: Cohort 4a- GSK30392940
Part B: Cohort 4b- GSK30392940
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD366.31101.67Not reportedNot reportedNot reported
Day 5: 4 hour (n=7, 0, 0)

Analysis denominator · Participants

GroupSource count
Part B: Cohort 3- GSK3039294 600 mg QD7
Part B: Cohort 4a- GSK30392940
Part B: Cohort 4b- GSK30392940
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD347.81115.59Not reportedNot reportedNot reported
Day 5: 6 hour (n=8, 0, 0)

Analysis denominator · Participants

GroupSource count
Part B: Cohort 3- GSK3039294 600 mg QD8
Part B: Cohort 4a- GSK30392940
Part B: Cohort 4b- GSK30392940
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD264.7972.97Not reportedNot reportedNot reported
Day 7: pre-dose (n=8, 0, 0)

Analysis denominator · Participants

GroupSource count
Part B: Cohort 3- GSK3039294 600 mg QD8
Part B: Cohort 4a- GSK30392940
Part B: Cohort 4b- GSK30392940
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD508.32301.64Not reportedNot reportedNot reported
Day 21 (n=8, 0, 0)

Analysis denominator · Participants

GroupSource count
Part B: Cohort 3- GSK3039294 600 mg QD8
Part B: Cohort 4a- GSK30392940
Part B: Cohort 4b- GSK30392940
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD33320.646252.46Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        6403.13
        value
        32318.69
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Day 1: pre-dose (n=8, 0, 0)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        761.37
        value
        4064.37
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Day 1: 2 hour (n=8, 0, 0)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        555.71
        value
        939.83
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Day 2: pre-dose (n=8, 0, 0)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        303.64
        value
        526.49
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Day 4: pre-dose (n=7, 0, 0)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        173.19
        value
        456.28
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Day 5: pre-dose (n=8, 0, 0)
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        232.88
        value
        506.16
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Day 5: 30 min (n=7, 0, 0)
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        174.85
        value
        458.72
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Day 5: 1 hour (n=8, 0, 0)
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        160.56
        value
        449.03
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Day 5: 2 hour (n=7, 0, 0)
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        101.67
        value
        366.31
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Day 5: 3 hour (n=8, 0, 0)
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        115.59
        value
        347.81
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Day 5: 4 hour (n=7, 0, 0)
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        72.97
        value
        264.79
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Day 5: 6 hour (n=8, 0, 0)
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        301.64
        value
        508.32
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Day 7: pre-dose (n=8, 0, 0)
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    units
    Participants
description
Blood samples were collected at specified time points for GSK3039294. Pharmacodynamic (PD) population consist of all participants who received at least one dose of study medication and who also had a baseline measurement and at least one post-treatment PD measure.
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
PD 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. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
reporting Status
POSTED
time Frame
Cohort 3:Days1(pre-dose, 2hour post-dose),2(pre-dose),4(pre-dose),5(pre-dose, 30min,1,2,3,4,6 hours post-dose),7(pre-dose)and 21post-dose;Cohort4:Days1(pre-dose, 2 hour post-dose),2(pre-dose),4(pre-dose), 5(pre-dose, and 2 hours post-dose) and 35post-dose
title
Part B: Plasma Serum Amyloid P Component (SAP) Level of GSK3039294
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice