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NCT02603172 · OUTCOME

Part A: Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) 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
Pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 and 48 hours post-dose

What was measured

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

Analysis population: PK population. 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 A: GSK3039294 200 mg

Participants received a single dose of GSK3039294 (dose level 1) 200 mg capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 1.

Part A: GSK3039294 600 mg

Participants received a single dose of GSK3039294 (dose level 2) 600 mg capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 1. The remaining participants received the same dose of GSK3039294 (dose level 3) 600 mg, capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 2. A washout period was maintained from Day 5 to 14 between two treatment cohorts.

Part A: GSK3039294 1200 mg

Participants received a single dose of GSK3039294 (dose level 4) 1200 mg, capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 2.

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 A: GSK3039294 200 mg8
Part A: GSK3039294 600 mg16
Part A: GSK3039294 1200 mg8

Reported measurements

GSK3039294: n= 0, 9, 4

Analysis denominator · Participants

GroupSource count
Part A: GSK3039294 200 mg0
Part A: GSK3039294 600 mg9
Part A: GSK3039294 1200 mg4
Values in h*ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 600 mg10.0347.06Not reportedNot reportedNot reported
Part A: GSK3039294 1200 mg18.7630.31Not reportedNot reportedNot reported
GSK2315698: n= 8, 16, 8

Analysis denominator · Participants

GroupSource count
Part A: GSK3039294 200 mg8
Part A: GSK3039294 600 mg16
Part A: GSK3039294 1200 mg8
Values in h*ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg7751.029.19Not reportedNot reportedNot reported
Part A: GSK3039294 600 mg23276.523.61Not reportedNot reportedNot reported
Part A: GSK3039294 1200 mg41261.414.75Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG001
        spread
        47.06
        value
        10.03
      2. group Id
        OG002
        spread
        30.31
        value
        18.76
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        4
      units
      Participants
    title
    GSK3039294: n= 0, 9, 4
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        29.19
        value
        7751.0
      2. group Id
        OG001
        spread
        23.61
        value
        23276.5
      3. group Id
        OG002
        spread
        14.75
        value
        41261.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        16
      3. group Id
        OG002
        value
        8
      units
      Participants
    title
    GSK2315698: n= 8, 16, 8
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      16
    3. group Id
      OG002
      value
      8
    units
    Participants
description
Blood samples were collected at specified time points for GSK3039294 and GSK2315698. AUC(0-t) was determined using standard non-compartmental methods.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants received a single dose of GSK3039294 (dose level 1) 200 mg capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 1.
    id
    OG000
    title
    Part A: GSK3039294 200 mg
  2. description
    Participants received a single dose of GSK3039294 (dose level 2) 600 mg capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 1. The remaining participants received the same dose of GSK3039294 (dose level 3) 600 mg, capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 2. A washout period was maintained from Day 5 to 14 between two treatment cohorts.
    id
    OG001
    title
    Part A: GSK3039294 600 mg
  3. description
    Participants received a single dose of GSK3039294 (dose level 4) 1200 mg, capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 2.
    id
    OG002
    title
    Part A: GSK3039294 1200 mg
param Type
GEOMETRIC_MEAN
population Description
PK population. 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
Pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 and 48 hours post-dose
title
Part A: Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) 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