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NCT02953652 · OUTCOME

Pharmacokinetics (Cmax-selected Sites)

Efficacy and Safety of Oral HBI-8000 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL) · Source last updated 2024-09-19

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

Measure
MEDIAN
Unit
ng/mL
Interval / dispersion
Full Range
Time frame
0 (predose) up to 72 hours postdose on C1D1 and 0 (predose) up to 4 hours postdose on C2D1

What was measured

Maximum observed plasma concentration (ng/mL), obtained directly from the observed concentration versus time data. Calculated for the C1D1 and C2D1 doses.

Analysis population: PK population includes all subjects, at the selected sites in Japan and all sites in South Korea, who have pretreatment baseline and at least 1 blood sample on study providing PK data for HBI-8000.

Groups in this outcome

C1D1

PK Sampling on C1D1

C2D1

PK Sampling on C2D1

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
C1D126
C2D18

Reported measurements

Source class 1
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
C1D1220Not reported71.9650Not reported
C2D1254Not reported118483Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        71.9
        upper Limit
        650
        value
        220
      2. group Id
        OG001
        lower Limit
        118
        upper Limit
        483
        value
        254
denoms
  1. counts
    1. group Id
      OG000
      value
      26
    2. group Id
      OG001
      value
      8
    units
    Participants
description
Maximum observed plasma concentration (ng/mL), obtained directly from the observed concentration versus time data. Calculated for the C1D1 and C2D1 doses.
dispersion Type
Full Range
groups
  1. description
    PK Sampling on C1D1
    id
    OG000
    title
    C1D1
  2. description
    PK Sampling on C2D1
    id
    OG001
    title
    C2D1
param Type
MEDIAN
population Description
PK population includes all subjects, at the selected sites in Japan and all sites in South Korea, who have pretreatment baseline and at least 1 blood sample on study providing PK data for HBI-8000.
reporting Status
POSTED
time Frame
0 (predose) up to 72 hours postdose on C1D1 and 0 (predose) up to 4 hours postdose on C2D1
title
Pharmacokinetics (Cmax-selected Sites)
type
OTHER_PRE_SPECIFIED
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice