Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02711137 · OUTCOME

AUC0-24: Area Under the Steady-state Plasma Concentration-time Curve of INCB057643 Administered as Monotherapy

Open-Label Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies · Source last updated 2025-10-21

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

Measure
MEAN
Unit
h*nM
Interval / dispersion
Standard Deviation
Time frame
Predose, 0.5, 1, 2, 4, 6, 8 hours on C1D8

What was measured

Area under the steady-state plasma concentration-time curve over 1 dosing interval from Hour 0 to 24 for QD administration of INCB057643 administered as monotherapy in fasted state

Analysis population: PK evaluable population includes all subjects who received at least 1 dose of study drug and had at least 1 PK sample collected and analyzed

Groups in this outcome

8mg QD INCB057643

Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the Part 1 TGA,TGB,TGC, and Part 2 TGA

12mg QD INCB057643

Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the Part 1 TGA,TGB, and Part 2 TGA

16mg QD INCB057643

Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the Part 1 TGA

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

Analysis denominator · Participants

GroupSource count
8mg QD INCB05764310
12mg QD INCB05764389
16mg QD INCB0576437

Reported measurements

Source class 1
Values in h*nM · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
8mg QD INCB057643194045.1Not reportedNot reportedNot reported
12mg QD INCB057643274043.2Not reportedNot reportedNot reported
16mg QD INCB057643361071.9Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        45.1
        value
        1940
      2. group Id
        OG001
        spread
        43.2
        value
        2740
      3. group Id
        OG002
        spread
        71.9
        value
        3610
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      89
    3. group Id
      OG002
      value
      7
    units
    Participants
description
Area under the steady-state plasma concentration-time curve over 1 dosing interval from Hour 0 to 24 for QD administration of INCB057643 administered as monotherapy in fasted state
dispersion Type
Standard Deviation
groups
  1. description
    Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the Part 1 TGA,TGB,TGC, and Part 2 TGA
    id
    OG000
    title
    8mg QD INCB057643
  2. description
    Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the Part 1 TGA,TGB, and Part 2 TGA
    id
    OG001
    title
    12mg QD INCB057643
  3. description
    Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the Part 1 TGA
    id
    OG002
    title
    16mg QD INCB057643
param Type
MEAN
population Description
PK evaluable population includes all subjects who received at least 1 dose of study drug and had at least 1 PK sample collected and analyzed
reporting Status
POSTED
time Frame
Predose, 0.5, 1, 2, 4, 6, 8 hours on C1D8
title
AUC0-24: Area Under the Steady-state Plasma Concentration-time Curve of INCB057643 Administered as Monotherapy
type
SECONDARY
unit Of Measure
h*nM

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

Preserved source evidence · Not medical advice