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NCT01587703 · OUTCOME

Time to Reach Cmax (Tmax) for 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
MEDIAN
Unit
Hours
Interval / dispersion
Full Range
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.

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

Source class 1
Values in Hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
GSK525762 80 mg Amorphous+6 mg Stable Isotope0.5833Not reported0.2503.250Not reported
GSK525762 80 mg Besylate+6 mg Stable Isotope0.8083Not reported0.5003.000Not reported
GSK525762 30 mg Besylate+6 mg Stable Isotope0.8333Not reported0.3001.017Not reported
GSK525762 80 mg Besylate Fed2.0000Not reported0.5006.050Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.250
        upper Limit
        3.250
        value
        0.5833
      2. group Id
        OG001
        lower Limit
        0.500
        upper Limit
        3.000
        value
        0.8083
      3. group Id
        OG002
        lower Limit
        0.300
        upper Limit
        1.017
        value
        0.8333
      4. group Id
        OG003
        lower Limit
        0.500
        upper Limit
        6.050
        value
        2.0000
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.
dispersion Type
Full Range
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
MEDIAN
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
Time to Reach Cmax (Tmax) for GSK525762-Besylate Sub-study
type
PRIMARY
unit Of Measure
Hours

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

Preserved source evidence · Not medical advice