Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02953652 · OUTCOME

Pharmacokinetics AUC (0-tau)

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*h/mL
Interval / dispersion
Full Range
Time frame
0 (predose) up to 72 hours postdose on C1D1

What was measured

Area under the plasma concentration time curve over the dosing interval tau (ng\*h/mL), calculated by linear up/log down trapezoidal summation. Calculated for the C1D1 dose only. Actual elapsed sampling time at tau and the corresponding plasma concentration was used in the calculation of this parameter. If concentrations fall to BLQ before or at tau, AUCall (area under the plasma concentration time curve from zero \[predose\] to the time of the last observation within the dosing interval, calculated by linear up/log down trapezoidal summation) was used as the estimate of this parameter.

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 C1D1

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

Reported measurements

Source class 1
Values in ng*h/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
C1D14740Not reported21308630Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2130
        upper Limit
        8630
        value
        4740
denoms
  1. counts
    1. group Id
      OG000
      value
      26
    units
    Participants
description
Area under the plasma concentration time curve over the dosing interval tau (ng\*h/mL), calculated by linear up/log down trapezoidal summation. Calculated for the C1D1 dose only. Actual elapsed sampling time at tau and the corresponding plasma concentration was used in the calculation of this parameter. If concentrations fall to BLQ before or at tau, AUCall (area under the plasma concentration time curve from zero \[predose\] to the time of the last observation within the dosing interval, calculated by linear up/log down trapezoidal summation) was used as the estimate of this parameter.
dispersion Type
Full Range
groups
  1. description
    PK Sampling C1D1
    id
    OG000
    title
    C1D1
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
title
Pharmacokinetics AUC (0-tau)
type
OTHER_PRE_SPECIFIED
unit Of Measure
ng*h/mL

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

Preserved source evidence · Not medical advice