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NCT01587703 · OUTCOME

Maximum Observed Concentration of 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
GEOMETRIC_MEAN
Unit
Nanogram per milliter
Interval / dispersion
Geometric Coefficient of Variation
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 Nanogram per milliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 1: GSK525762 20 mg BID231.6870.6Not reportedNot reportedNot reported
Part 1: GSK525762 30 mg BID628.0140.0Not reportedNot reportedNot reported
Part 1: GSK525762 40 mg BID703.3134.2Not reportedNot reportedNot 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 Nanogram per milliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 1: GSK525762 20 mg BID166.6262.0Not reportedNot reportedNot reported
Part 1: GSK525762 30 mg BID445.1727.6Not reportedNot reportedNot reported
Part 1: GSK525762 40 mg BID425.7629.3Not reportedNot reportedNot 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 Nanogram per milliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 1: GSK525762 20 mg BID284.7187.1Not reportedNot reportedNot reported
Part 1: GSK525762 30 mg BID604.3866.4Not reportedNot reportedNot reported
Part 1: GSK525762 40 mg BID419.1518.1Not reportedNot reportedNot 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 Nanogram per milliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 1: GSK525762 20 mg BID256.0894.0Not reportedNot reportedNot reported
Part 1: GSK525762 30 mg BID263.7241.3Not reportedNot reportedNot reported
Part 1: GSK525762 40 mg BID229.9134.8Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        70.6
        value
        231.68
      2. group Id
        OG001
        spread
        40.0
        value
        628.01
      3. group Id
        OG002
        spread
        34.2
        value
        703.31
    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
        spread
        62.0
        value
        166.62
      2. group Id
        OG001
        spread
        27.6
        value
        445.17
      3. group Id
        OG002
        spread
        29.3
        value
        425.76
    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
        spread
        87.1
        value
        284.71
      2. group Id
        OG001
        spread
        66.4
        value
        604.38
      3. group Id
        OG002
        spread
        18.1
        value
        419.15
    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
        spread
        94.0
        value
        256.08
      2. group Id
        OG001
        spread
        41.3
        value
        263.72
      3. group Id
        OG002
        spread
        34.8
        value
        229.91
    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
Geometric Coefficient of Variation
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
GEOMETRIC_MEAN
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
Maximum Observed Concentration of GSK525762-Part 1 BID
type
SECONDARY
unit Of Measure
Nanogram per milliter

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Preserved source evidence · Not medical advice