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NCT01587703 · OUTCOME

Tmax for GSK525762-Part 1 BID

A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK525762 in Subjects With NUT Midline Carcinoma (NMC) and Other Cancers · Source last updated 2020-03-16

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
Hour
Interval / dispersion
Full Range
Time frame
pre-dose,0.25,0.5,1,2,4,8,12 hours post-AM dose at Week1Day1 and Week3 Day 4; Week1 Day5(0.5, 3 hours post-AM dose); pre-dose, 0.25,0.5,1,2,4,8,12, 36 hours post-PM dose at Week1Day1 and Week3 Day4

What was measured

Blood samples were collected at indicated time points post ante-meridiem (AM) and post-meridiem (PM) dose for pharmacokinetic analysis of GSK525762.

Analysis population: PK Parameter Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)

Groups in this outcome

Part 1: GSK525762 20 mg BID

Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.

Part 1: GSK525762 30 mg BID

Participants were administered twice daily oral dose of 30 mg GSK525762.

Part 1: GSK525762 40 mg BID

Participants were administered twice daily oral dose of 40 mg GSK525762.

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 1: GSK525762 20 mg BID4
Part 1: GSK525762 30 mg BID10
Part 1: GSK525762 40 mg BID5

Reported measurements

Week1 AM dose;n=4,10,5

Analysis denominator · Participants

GroupSource count
Part 1: GSK525762 20 mg BID4
Part 1: GSK525762 30 mg BID10
Part 1: GSK525762 40 mg BID5
Values in Hour · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1: GSK525762 20 mg BID1.5500Not reported0.5834.283Not reported
Part 1: GSK525762 30 mg BID0.9667Not reported0.5502.100Not reported
Part 1: GSK525762 40 mg BID0.5500Not reported0.5171.033Not reported
Week1 PM dose;n=4,9,5

Analysis denominator · Participants

GroupSource count
Part 1: GSK525762 20 mg BID4
Part 1: GSK525762 30 mg BID9
Part 1: GSK525762 40 mg BID5
Values in Hour · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1: GSK525762 20 mg BID1.9583Not reported1.9174.000Not reported
Part 1: GSK525762 30 mg BID1.9667Not reported0.9674.167Not reported
Part 1: GSK525762 40 mg BID1.9833Not reported1.0177.733Not reported
Week3 AM dose;n=3,7,3

Analysis denominator · Participants

GroupSource count
Part 1: GSK525762 20 mg BID3
Part 1: GSK525762 30 mg BID7
Part 1: GSK525762 40 mg BID3
Values in Hour · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1: GSK525762 20 mg BID1.1833Not reported1.1672.067Not reported
Part 1: GSK525762 30 mg BID1.0667Not reported0.2502.017Not reported
Part 1: GSK525762 40 mg BID0.5833Not reported0.1831.000Not reported
Week3 PM dose;n=3,6,3

Analysis denominator · Participants

GroupSource count
Part 1: GSK525762 20 mg BID3
Part 1: GSK525762 30 mg BID6
Part 1: GSK525762 40 mg BID3
Values in Hour · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1: GSK525762 20 mg BID1.0000Not reported0.5002.083Not reported
Part 1: GSK525762 30 mg BID1.4500Not reported0.0002.083Not reported
Part 1: GSK525762 40 mg BID2.0667Not reported1.9002.067Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.583
        upper Limit
        4.283
        value
        1.5500
      2. group Id
        OG001
        lower Limit
        0.550
        upper Limit
        2.100
        value
        0.9667
      3. group Id
        OG002
        lower Limit
        0.517
        upper Limit
        1.033
        value
        0.5500
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        5
      units
      Participants
    title
    Week1 AM dose;n=4,10,5
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.917
        upper Limit
        4.000
        value
        1.9583
      2. group Id
        OG001
        lower Limit
        0.967
        upper Limit
        4.167
        value
        1.9667
      3. group Id
        OG002
        lower Limit
        1.017
        upper Limit
        7.733
        value
        1.9833
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        5
      units
      Participants
    title
    Week1 PM dose;n=4,9,5
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.167
        upper Limit
        2.067
        value
        1.1833
      2. group Id
        OG001
        lower Limit
        0.250
        upper Limit
        2.017
        value
        1.0667
      3. group Id
        OG002
        lower Limit
        0.183
        upper Limit
        1.000
        value
        0.5833
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        3
      units
      Participants
    title
    Week3 AM dose;n=3,7,3
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.500
        upper Limit
        2.083
        value
        1.0000
      2. group Id
        OG001
        lower Limit
        0.000
        upper Limit
        2.083
        value
        1.4500
      3. group Id
        OG002
        lower Limit
        1.900
        upper Limit
        2.067
        value
        2.0667
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        3
      units
      Participants
    title
    Week3 PM dose;n=3,6,3
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      5
    units
    Participants
description
Blood samples were collected at indicated time points post ante-meridiem (AM) and post-meridiem (PM) dose for pharmacokinetic analysis of GSK525762.
dispersion Type
Full Range
groups
  1. description
    Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
    id
    OG000
    title
    Part 1: GSK525762 20 mg BID
  2. description
    Participants were administered twice daily oral dose of 30 mg GSK525762.
    id
    OG001
    title
    Part 1: GSK525762 30 mg BID
  3. description
    Participants were administered twice daily oral dose of 40 mg GSK525762.
    id
    OG002
    title
    Part 1: GSK525762 40 mg BID
param Type
MEDIAN
population Description
PK Parameter Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
reporting Status
POSTED
time Frame
pre-dose,0.25,0.5,1,2,4,8,12 hours post-AM dose at Week1Day1 and Week3 Day 4; Week1 Day5(0.5, 3 hours post-AM dose); pre-dose, 0.25,0.5,1,2,4,8,12, 36 hours post-PM dose at Week1Day1 and Week3 Day4
title
Tmax for GSK525762-Part 1 BID
type
SECONDARY
unit Of Measure
Hour

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Preserved source evidence · Not medical advice