Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02711137 · OUTCOME

AUC0-t: Area Under the Single-dose Plasma Concentration-time Curve of INCB057643

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 C1D1

What was measured

Area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration 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 INCB05764312
12mg QD INCB05764399
16mg QD INCB0576437

Reported measurements

Source class 1
Values in h*nM · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
8mg QD INCB057643209050.1Not reportedNot reportedNot reported
12mg QD INCB057643255039.5Not reportedNot reportedNot reported
16mg QD INCB057643321034.3Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        50.1
        value
        2090
      2. group Id
        OG001
        spread
        39.5
        value
        2550
      3. group Id
        OG002
        spread
        34.3
        value
        3210
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    2. group Id
      OG001
      value
      99
    3. group Id
      OG002
      value
      7
    units
    Participants
description
Area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration 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 C1D1
title
AUC0-t: Area Under the Single-dose Plasma Concentration-time Curve of INCB057643
type
SECONDARY
unit Of Measure
h*nM

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

Preserved source evidence · Not medical advice