NCT01587703 · OUTCOME

Maximum Observed Concentration (Cmax) 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: 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.

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

Group	Source count
GSK525762 80 mg Amorphous+6 mg Stable Isotope	9
GSK525762 80 mg Besylate+6 mg Stable Isotope	10
GSK525762 30 mg Besylate+6 mg Stable Isotope	10
GSK525762 80 mg Besylate Fed	8

Reported measurements

Source class 1

Values in Nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
GSK525762 80 mg Amorphous+6 mg Stable Isotope	1431.41	51.3	Not reported	Not reported	Not reported
GSK525762 80 mg Besylate+6 mg Stable Isotope	1483.21	49.8	Not reported	Not reported	Not reported
GSK525762 30 mg Besylate+6 mg Stable Isotope	655.33	21.1	Not reported	Not reported	Not reported
GSK525762 80 mg Besylate Fed	1305.59	46.6	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
51.3
value
1431.41
group Id
OG001
spread
49.8
value
1483.21
group Id
OG002
spread
21.1
value
655.33
group Id
OG003
spread
46.6
value
1305.59

denoms

counts
group Id
OG000
value
9
group Id
OG001
value
10
group Id
OG002
value
10
group Id
OG003
value
8
units
Participants

description

Blood samples for pharmacokinetic analysis of GSK525762 were collected at the indicated time points.

dispersion Type

Geometric Coefficient of Variation

groups

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
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
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
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

Maximum Observed Concentration (Cmax) of GSK525762-Besylate Sub-study

type

PRIMARY

unit Of Measure

Nanograms per milliliter

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

Preserved source evidence · Not medical advice