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NCT01587703 · OUTCOME

Area Under the Concentration-time Curve (AUC) From Time Zero to 24 Hours(AUC[0 to 24]); AUC From Time 0 to Last Quantifiable Concentration (AUC [0 to t]) and AUC Extrapolated to Infinity (AUC[0 to Inf]) of GSK525762-Besylate Sub-study

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
Hours*nanograms per milliliter
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Week1 Day1, Day3 and Week2 Day1 (pre-dose,0.25,0.5,1,1.5,2,3,4,6,8,24,48 hours post-dose)

What was measured

Blood samples for pharmacokinetic analysis of GSK525762 were collected at the indicated time points. Besylate sub-study pharmacokinetic (PK) Parameter Population consisted of all participants in the PK Parameter Population who participated in the besylate substudy.

Analysis population: Besylate Sub-Study PK Parameter Population. Only those participants with data available at the specified time points were analyzed.

Groups in this outcome

GSK525762 80 mg Amorphous+6 mg Stable Isotope

Participants were administered GSK525762 80 mg amorphous free-base tablet along with 6 mg stable isotope in the fasted state.

GSK525762 80 mg Besylate+6 mg Stable Isotope

Participants were administered GSK525762 80 mg besylate tablet along with 6 mg stable isotope in solution in fasted state.

GSK525762 30 mg Besylate+6 mg Stable Isotope

Participants were administered GSK525762 30 mg besylate tablet along with 6 mg stable isotope in solution in fasted state.

GSK525762 80 mg Besylate Fed

Participants were administered GSK525762 80 mg besylate tablet along with Food and Drug Administration (FDA) recommended high fat breakfast.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
GSK525762 80 mg Amorphous+6 mg Stable Isotope9
GSK525762 80 mg Besylate+6 mg Stable Isotope10
GSK525762 30 mg Besylate+6 mg Stable Isotope10
GSK525762 80 mg Besylate Fed8

Reported measurements

AUC(0 to 24)
Values in Hours*nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
GSK525762 80 mg Amorphous+6 mg Stable Isotope6954.359.1Not reportedNot reportedNot reported
GSK525762 80 mg Besylate+6 mg Stable Isotope7377.944.7Not reportedNot reportedNot reported
GSK525762 30 mg Besylate+6 mg Stable Isotope2977.342.8Not reportedNot reportedNot reported
GSK525762 80 mg Besylate Fed9123.845.2Not reportedNot reportedNot reported
AUC(0 to inf)
Values in Hours*nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
GSK525762 80 mg Amorphous+6 mg Stable Isotope7292.062.1Not reportedNot reportedNot reported
GSK525762 80 mg Besylate+6 mg Stable Isotope7703.449.9Not reportedNot reportedNot reported
GSK525762 30 mg Besylate+6 mg Stable Isotope3096.945.0Not reportedNot reportedNot reported
GSK525762 80 mg Besylate Fed9727.748.5Not reportedNot reportedNot reported
AUC(0 to t)
Values in Hours*nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
GSK525762 80 mg Amorphous+6 mg Stable Isotope7227.161.6Not reportedNot reportedNot reported
GSK525762 80 mg Besylate+6 mg Stable Isotope7657.649.9Not reportedNot reportedNot reported
GSK525762 30 mg Besylate+6 mg Stable Isotope3053.944.4Not reportedNot reportedNot reported
GSK525762 80 mg Besylate Fed9597.148.9Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        59.1
        value
        6954.3
      2. group Id
        OG001
        spread
        44.7
        value
        7377.9
      3. group Id
        OG002
        spread
        42.8
        value
        2977.3
      4. group Id
        OG003
        spread
        45.2
        value
        9123.8
    title
    AUC(0 to 24)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        62.1
        value
        7292.0
      2. group Id
        OG001
        spread
        49.9
        value
        7703.4
      3. group Id
        OG002
        spread
        45.0
        value
        3096.9
      4. group Id
        OG003
        spread
        48.5
        value
        9727.7
    title
    AUC(0 to inf)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        61.6
        value
        7227.1
      2. group Id
        OG001
        spread
        49.9
        value
        7657.6
      3. group Id
        OG002
        spread
        44.4
        value
        3053.9
      4. group Id
        OG003
        spread
        48.9
        value
        9597.1
    title
    AUC(0 to t)
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      10
    4. group Id
      OG003
      value
      8
    units
    Participants
description
Blood samples for pharmacokinetic analysis of GSK525762 were collected at the indicated time points. Besylate sub-study pharmacokinetic (PK) Parameter Population consisted of all participants in the PK Parameter Population who participated in the besylate substudy.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants were administered GSK525762 80 mg amorphous free-base tablet along with 6 mg stable isotope in the fasted state.
    id
    OG000
    title
    GSK525762 80 mg Amorphous+6 mg Stable Isotope
  2. description
    Participants were administered GSK525762 80 mg besylate tablet along with 6 mg stable isotope in solution in fasted state.
    id
    OG001
    title
    GSK525762 80 mg Besylate+6 mg Stable Isotope
  3. description
    Participants were administered GSK525762 30 mg besylate tablet along with 6 mg stable isotope in solution in fasted state.
    id
    OG002
    title
    GSK525762 30 mg Besylate+6 mg Stable Isotope
  4. description
    Participants were administered GSK525762 80 mg besylate tablet along with Food and Drug Administration (FDA) recommended high fat breakfast.
    id
    OG003
    title
    GSK525762 80 mg Besylate Fed
param Type
GEOMETRIC_MEAN
population Description
Besylate Sub-Study PK Parameter Population. Only those participants with data available at the specified time points were analyzed.
reporting Status
POSTED
time Frame
Week1 Day1, Day3 and Week2 Day1 (pre-dose,0.25,0.5,1,1.5,2,3,4,6,8,24,48 hours post-dose)
title
Area Under the Concentration-time Curve (AUC) From Time Zero to 24 Hours(AUC[0 to 24]); AUC From Time 0 to Last Quantifiable Concentration (AUC [0 to t]) and AUC Extrapolated to Infinity (AUC[0 to Inf]) of GSK525762-Besylate Sub-study
type
PRIMARY
unit Of Measure
Hours*nanograms per milliliter

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

Preserved source evidence · Not medical advice