NCT03614728 · OUTCOME

Part 1: Area Under Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within Participant Across All Treatments (AUC[0-t]) of GSK3326595 Following Administration of Single Dose

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: Hours*nanogram per milliliter
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Day 1:Pre-dose(within 1 hour prior to dosing),5minute(+/-2minute),30minute(+/-5minute),1hour(+/-5minute),2hours(+/-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.

Analysis population: PK Population

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	13
Part 1: GSK3326595 300 mg	17

Reported measurements

Source class 1

Values in Hours*nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK3326595 400 mg	6667.4570	56.989	Not reported	Not reported	Not reported
Part 1: GSK3326595 300 mg	5189.2734	58.269	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
56.989
value
6667.4570
group Id
OG001
spread
58.269
value
5189.2734

denoms

counts
group Id
OG000
value
13
group Id
OG001
value
17
units
Participants

description

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3326595.

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

reporting Status

POSTED

time Frame

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

title

Part 1: Area Under Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within Participant Across All Treatments (AUC[0-t]) of GSK3326595 Following Administration of Single Dose

type

SECONDARY

unit Of Measure

Hours*nanogram per milliliter

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

Preserved source evidence · Not medical advice