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NCT02603172 · OUTCOME

Part B: Area Under the Concentration-time Curve From Time Zero to 6 Hours Post Dose (AUC[0-6]) 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
GEOMETRIC_MEAN
Unit
h*ng/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cohort 3- Day 4 and 5: pre-dose, and 0.5, 1, 2, 3, 4, and 6 hours post-dose; Cohort 4: Day 4 (pre-dose), Day 5 (pre-dose and 0.5, 1, 2, 3, 4, and 6 hours post-dose)

What was measured

Blood samples were collected at specified time points for GSK3039294 and GSK2315698. AUC(0-6) was determined using standard non-compartmental methods.

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 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

GSK3039294: Day 4 (n= 0, 0, 0)

Analysis denominator · Participants

GroupSource count
Part B: Cohort 3- GSK3039294 600 mg QD0
Part B: Cohort 4a- GSK30392940
Part B: Cohort 4b- GSK30392940
GSK2315698: Day 4 (n= 6, 0, 0)

Analysis denominator · Participants

GroupSource count
Part B: Cohort 3- GSK3039294 600 mg QD6
Part B: Cohort 4a- GSK30392940
Part B: Cohort 4b- GSK30392940
Values in h*ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD6899.819.72Not reportedNot reportedNot reported
GSK3039294: Day 5 (n= 0, 0, 0)

Analysis denominator · Participants

GroupSource count
Part B: Cohort 3- GSK3039294 600 mg QD0
Part B: Cohort 4a- GSK30392940
Part B: Cohort 4b- GSK30392940
GSK2315698: Day 5 (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 h*ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD8900.135.27Not reportedNot reportedNot reported
Complete source fields
classes
  1. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    GSK3039294: Day 4 (n= 0, 0, 0)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.72
        value
        6899.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    GSK2315698: Day 4 (n= 6, 0, 0)
  3. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    GSK3039294: Day 5 (n= 0, 0, 0)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        35.27
        value
        8900.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    GSK2315698: Day 5 (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 and GSK2315698. AUC(0-6) was determined using standard non-compartmental methods.
dispersion Type
Geometric Coefficient of Variation
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
GEOMETRIC_MEAN
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 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- Day 4 and 5: pre-dose, and 0.5, 1, 2, 3, 4, and 6 hours post-dose; Cohort 4: Day 4 (pre-dose), Day 5 (pre-dose and 0.5, 1, 2, 3, 4, and 6 hours post-dose)
title
Part B: Area Under the Concentration-time Curve From Time Zero to 6 Hours Post Dose (AUC[0-6]) of GSK3039294 and GSK2315698
type
SECONDARY
unit Of Measure
h*ng/mL

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

Preserved source evidence · Not medical advice