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NCT02903914 · OUTCOME

Tmax of INCB001158 in the Fed and Fasted States Following Multiple Doses for Part 1A to Assess the Effect of Food

Arginase Inhibitor INCB001158 as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced/Metastatic Solid Tumors · Source last updated 2025-08-05

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

Measure
MEDIAN
Unit
hours
Interval / dispersion
Full Range
Time frame
Fasted: Cycle 1 Day 15: predose; 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose. Fed: Cycle 2 Day 8: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose

What was measured

tmax was defined as the time of the maximum observed concentration of INCB001158.

Analysis population: PK Population. Only participants with available data were analyzed.

Groups in this outcome

Part 1A: INCB001158 50 mg

INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.

Part 1A: INCB001158 75 mg

INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.

Part 1A: INCB001158 100 mg

INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.

Part 1A: INCB001158 150 mg

INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.

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 1A: INCB001158 50 mg6
Part 1A: INCB001158 75 mg7
Part 1A: INCB001158 100 mg7
Part 1A: INCB001158 150 mg6

Reported measurements

Fasted

Analysis denominator · Participants

GroupSource count
Part 1A: INCB001158 50 mg6
Part 1A: INCB001158 75 mg7
Part 1A: INCB001158 100 mg7
Part 1A: INCB001158 150 mg6
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1A: INCB001158 50 mg2.0Not reported2.04.0Not reported
Part 1A: INCB001158 75 mg4.0Not reported2.04.3Not reported
Part 1A: INCB001158 100 mg4.0Not reported2.15.9Not reported
Part 1A: INCB001158 150 mg2.0Not reported1.94.2Not reported
Fed

Analysis denominator · Participants

GroupSource count
Part 1A: INCB001158 50 mg6
Part 1A: INCB001158 75 mg6
Part 1A: INCB001158 100 mg6
Part 1A: INCB001158 150 mg3
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1A: INCB001158 50 mg4.0Not reported3.97.2Not reported
Part 1A: INCB001158 75 mg4.0Not reported4.06.1Not reported
Part 1A: INCB001158 100 mg4.0Not reported3.86.0Not reported
Part 1A: INCB001158 150 mg4.0Not reported4.06.2Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Description
    Fed versus Fasted
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    0.0441
    statistical Method
    Wilcoxon (Mann-Whitney)
  2. group Description
    Fed versus Fasted
    group Ids
    1. OG001
    non Inferiority Type
    OTHER
    p Value
    0.4092
    statistical Method
    Wilcoxon (Mann-Whitney)
  3. group Description
    Fed versus Fasted
    group Ids
    1. OG002
    non Inferiority Type
    OTHER
    p Value
    0.7748
    statistical Method
    Wilcoxon (Mann-Whitney)
  4. group Description
    Fed versus Fasted
    group Ids
    1. OG003
    non Inferiority Type
    OTHER
    p Value
    0.1948
    statistical Method
    Wilcoxon (Mann-Whitney)
Complete source fields
analyses
  1. group Description
    Fed versus Fasted
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    0.0441
    statistical Method
    Wilcoxon (Mann-Whitney)
  2. group Description
    Fed versus Fasted
    group Ids
    1. OG001
    non Inferiority Type
    OTHER
    p Value
    0.4092
    statistical Method
    Wilcoxon (Mann-Whitney)
  3. group Description
    Fed versus Fasted
    group Ids
    1. OG002
    non Inferiority Type
    OTHER
    p Value
    0.7748
    statistical Method
    Wilcoxon (Mann-Whitney)
  4. group Description
    Fed versus Fasted
    group Ids
    1. OG003
    non Inferiority Type
    OTHER
    p Value
    0.1948
    statistical Method
    Wilcoxon (Mann-Whitney)
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.0
        upper Limit
        4.0
        value
        2.0
      2. group Id
        OG001
        lower Limit
        2.0
        upper Limit
        4.3
        value
        4.0
      3. group Id
        OG002
        lower Limit
        2.1
        upper Limit
        5.9
        value
        4.0
      4. group Id
        OG003
        lower Limit
        1.9
        upper Limit
        4.2
        value
        2.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        7
      4. group Id
        OG003
        value
        6
      units
      Participants
    title
    Fasted
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.9
        upper Limit
        7.2
        value
        4.0
      2. group Id
        OG001
        lower Limit
        4.0
        upper Limit
        6.1
        value
        4.0
      3. group Id
        OG002
        lower Limit
        3.8
        upper Limit
        6.0
        value
        4.0
      4. group Id
        OG003
        lower Limit
        4.0
        upper Limit
        6.2
        value
        4.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        3
      units
      Participants
    title
    Fed
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      7
    4. group Id
      OG003
      value
      6
    units
    Participants
description
tmax was defined as the time of the maximum observed concentration of INCB001158.
dispersion Type
Full Range
groups
  1. description
    INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
    id
    OG000
    title
    Part 1A: INCB001158 50 mg
  2. description
    INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
    id
    OG001
    title
    Part 1A: INCB001158 75 mg
  3. description
    INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
    id
    OG002
    title
    Part 1A: INCB001158 100 mg
  4. description
    INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
    id
    OG003
    title
    Part 1A: INCB001158 150 mg
param Type
MEDIAN
population Description
PK Population. Only participants with available data were analyzed.
reporting Status
POSTED
time Frame
Fasted: Cycle 1 Day 15: predose; 0.5, 1, 2, 4, 6, 8, and 12 hours post-dose. Fed: Cycle 2 Day 8: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose
title
Tmax of INCB001158 in the Fed and Fasted States Following Multiple Doses for Part 1A to Assess the Effect of Food
type
SECONDARY
unit Of Measure
hours

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Preserved source evidence · Not medical advice