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NCT03614728 · OUTCOME

Part 2: t1/2 of GSK3326595 Following Administration of Repeat 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
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Day 8: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 planned to be collected at indicated time points for pharmacokinetic analysis of GSK3326595.

Analysis population: PK Population. Data was not collected as no participants were enrolled in Part 2.

Groups in this outcome

Part 2-Dose Escalation: GSK3326595+5-Azacitidine

Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.

Part 2-Dose Expansion: GSK3326595+5-Azacitidine

Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 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 2-Dose Escalation: GSK3326595+5-Azacitidine0
Part 2-Dose Expansion: GSK3326595+5-Azacitidine0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    units
    Participants
description
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of GSK3326595.
groups
  1. description
    Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.
    id
    OG000
    title
    Part 2-Dose Escalation: GSK3326595+5-Azacitidine
  2. description
    Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.
    id
    OG001
    title
    Part 2-Dose Expansion: GSK3326595+5-Azacitidine
population Description
PK Population. Data was not collected as no participants were enrolled in Part 2.
reporting Status
POSTED
time Frame
Day 8: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 2: t1/2 of GSK3326595 Following Administration of Repeat Dose
type
SECONDARY

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

Preserved source evidence · Not medical advice