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NCT03614728 · OUTCOME

Part 1: Time of Maximum Concentration Observed (Tmax) 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
MEDIAN
Unit
Hours
Interval / dispersion
Full Range
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

GroupSource count
Part 1: GSK3326595 400 mg13
Part 1: GSK3326595 300 mg17

Reported measurements

Source class 1
Values in Hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1: GSK3326595 400 mg2.0000Not reported0.9504.167Not reported
Part 1: GSK3326595 300 mg2.1667Not reported0.5005.933Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.950
        upper Limit
        4.167
        value
        2.0000
      2. group Id
        OG001
        lower Limit
        0.500
        upper Limit
        5.933
        value
        2.1667
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    2. group Id
      OG001
      value
      17
    units
    Participants
description
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3326595.
dispersion Type
Full Range
groups
  1. 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
  2. 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
MEDIAN
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: Time of Maximum Concentration Observed (Tmax) of GSK3326595 Following Administration of Single Dose
type
SECONDARY
unit Of Measure
Hours

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

Preserved source evidence · Not medical advice