NCT03614728 · OUTCOME

Part 1: Time Invariance Following Administration of GSK3326595

Study to Investigate the Safety and Clinical Activity of GSK3326595 and Other Agents to Treat Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) · Source last updated 2023-02-06

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

Measure: GEOMETRIC_MEAN
Unit: Ratio
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Days1and15:Pre-dose(within 1hour prior to dosing),5minute(+/-2minute),30minute(+/-5minute),1hour(+/-5minute),2hour(+/-5minute),3hours(+/-5minute),4hours(+/-10minute),6hours(+/-10minute),8hours(+/-15minute),12hours(+/-2hour),24hours(+/-2hour)post-dose

What was measured

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3326595. Time invariance was calculated as the ratio of AUC(0-24) on Day 15 divided by AUC(0-infinity) on Day 1 for GSK3326595.

Analysis population: PK Population. Only those participants with data available at the specified time points were analyzed.

Groups in this outcome

Part 1: GSK3326595 400 mg

Participants received GSK3326595 400 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.

Part 1: GSK3326595 300 mg

Participants received GSK3326595 300 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.

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
Part 1: GSK3326595 400 mg	9
Part 1: GSK3326595 300 mg	16

Reported measurements

Source class 1

Values in Ratio · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK3326595 400 mg	1.3032	46.471	Not reported	Not reported	Not reported
Part 1: GSK3326595 300 mg	0.9485	57.938	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
46.471
value
1.3032
group Id
OG001
spread
57.938
value
0.9485

denoms

counts
group Id
OG000
value
9
group Id
OG001
value
16
units
Participants

description

dispersion Type

Geometric Coefficient of Variation

groups

description
Participants received GSK3326595 400 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.
id
OG000
title
Part 1: GSK3326595 400 mg
description
Participants received GSK3326595 300 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.
id
OG001
title
Part 1: GSK3326595 300 mg

param Type

GEOMETRIC_MEAN

population Description

PK Population. Only those participants with data available at the specified time points were analyzed.

reporting Status

POSTED

time Frame

Days1and15:Pre-dose(within 1hour prior to dosing),5minute(+/-2minute),30minute(+/-5minute),1hour(+/-5minute),2hour(+/-5minute),3hours(+/-5minute),4hours(+/-10minute),6hours(+/-10minute),8hours(+/-15minute),12hours(+/-2hour),24hours(+/-2hour)post-dose

title

Part 1: Time Invariance Following Administration of GSK3326595

type

SECONDARY

unit Of Measure

Ratio

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

Preserved source evidence · Not medical advice