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NCT02603172 · OUTCOME

Part A: Time to Reach Cmax (Tmax) 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
MEDIAN
Unit
Hours
Interval / dispersion
Full Range
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. tmax 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= 1, 10, 6

Analysis denominator · Participants

GroupSource count
Part A: GSK3039294 200 mg1
Part A: GSK3039294 600 mg10
Part A: GSK3039294 1200 mg6
Values in Hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg0.750Not reported0.750.75Not reported
Part A: GSK3039294 600 mg0.500Not reported0.251.50Not reported
Part A: GSK3039294 1200 mg0.867Not reported0.251.52Not 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 Hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg5.000Not reported3.025.12Not reported
Part A: GSK3039294 600 mg6.000Not reported4.008.27Not reported
Part A: GSK3039294 1200 mg6.000Not reported1.5808.00Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.75
        upper Limit
        0.75
        value
        0.750
      2. group Id
        OG001
        lower Limit
        0.25
        upper Limit
        1.50
        value
        0.500
      3. group Id
        OG002
        lower Limit
        0.25
        upper Limit
        1.52
        value
        0.867
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        6
      units
      Participants
    title
    GSK3039294: n= 1, 10, 6
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.02
        upper Limit
        5.12
        value
        5.000
      2. group Id
        OG001
        lower Limit
        4.00
        upper Limit
        8.27
        value
        6.000
      3. group Id
        OG002
        lower Limit
        1.580
        upper Limit
        8.00
        value
        6.000
    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. tmax was determined using standard non-compartmental methods.
dispersion Type
Full Range
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
MEDIAN
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: Time to Reach Cmax (Tmax) of GSK3039294 and GSK2315698
type
SECONDARY
unit Of Measure
Hours

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

Preserved source evidence · Not medical advice