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NCT02903914 · OUTCOME

Cmax 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
GEOMETRIC_MEAN
Unit
ng/mL
Interval / dispersion
Geometric Coefficient of Variation
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

Cmax was defined as the maximum observed concentration of INCB001158.

Analysis population: PK Population. Only participants with available date 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 mg5
Part 1A: INCB001158 75 mg5
Part 1A: INCB001158 100 mg7
Part 1A: INCB001158 150 mg6
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 1A: INCB001158 50 mg9040.19Not reportedNot reportedNot reported
Part 1A: INCB001158 75 mg18400.31Not reportedNot reportedNot reported
Part 1A: INCB001158 100 mg19900.26Not reportedNot reportedNot reported
Part 1A: INCB001158 150 mg33700.30Not reportedNot reportedNot 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 ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 1A: INCB001158 50 mg9550.38Not reportedNot reportedNot reported
Part 1A: INCB001158 75 mg18600.22Not reportedNot reportedNot reported
Part 1A: INCB001158 100 mg21300.31Not reportedNot reportedNot reported
Part 1A: INCB001158 150 mg41700.32Not reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    0.753
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    1.483
    group Description
    Fed versus Fasted
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    0.7702
    param Type
    pairwise GMR
    param Value
    1.057
    statistical Comment
    1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)
    statistical Method
    ANOVA
  2. ci Lower Limit
    0.762
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    1.346
    group Description
    Fed versus Fasted
    group Ids
    1. OG001
    non Inferiority Type
    OTHER
    p Value
    0.9384
    param Type
    pairwise GMR
    param Value
    1.012
    statistical Comment
    1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)
    statistical Method
    ANOVA
  3. ci Lower Limit
    0.809
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    1.415
    group Description
    Fed versus Fasted
    group Ids
    1. OG002
    non Inferiority Type
    OTHER
    p Value
    0.6733
    param Type
    pairwise GMR
    param Value
    1.070
    statistical Comment
    1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)
    statistical Method
    ANOVA
  4. ci Lower Limit
    0.830
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    1.847
    group Description
    Fed versus Fasted
    group Ids
    1. OG003
    non Inferiority Type
    OTHER
    p Value
    0.3456
    param Type
    pairwise GMR
    param Value
    1.238
    statistical Comment
    1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)
    statistical Method
    ANOVA
Complete source fields
analyses
  1. ci Lower Limit
    0.753
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    1.483
    group Description
    Fed versus Fasted
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    0.7702
    param Type
    pairwise GMR
    param Value
    1.057
    statistical Comment
    1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)
    statistical Method
    ANOVA
  2. ci Lower Limit
    0.762
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    1.346
    group Description
    Fed versus Fasted
    group Ids
    1. OG001
    non Inferiority Type
    OTHER
    p Value
    0.9384
    param Type
    pairwise GMR
    param Value
    1.012
    statistical Comment
    1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)
    statistical Method
    ANOVA
  3. ci Lower Limit
    0.809
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    1.415
    group Description
    Fed versus Fasted
    group Ids
    1. OG002
    non Inferiority Type
    OTHER
    p Value
    0.6733
    param Type
    pairwise GMR
    param Value
    1.070
    statistical Comment
    1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)
    statistical Method
    ANOVA
  4. ci Lower Limit
    0.830
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    1.847
    group Description
    Fed versus Fasted
    group Ids
    1. OG003
    non Inferiority Type
    OTHER
    p Value
    0.3456
    param Type
    pairwise GMR
    param Value
    1.238
    statistical Comment
    1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)
    statistical Method
    ANOVA
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.19
        value
        904
      2. group Id
        OG001
        spread
        0.31
        value
        1840
      3. group Id
        OG002
        spread
        0.26
        value
        1990
      4. group Id
        OG003
        spread
        0.30
        value
        3370
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        7
      4. group Id
        OG003
        value
        6
      units
      Participants
    title
    Fasted
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.38
        value
        955
      2. group Id
        OG001
        spread
        0.22
        value
        1860
      3. group Id
        OG002
        spread
        0.31
        value
        2130
      4. group Id
        OG003
        spread
        0.32
        value
        4170
    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
Cmax was defined as the maximum observed concentration of INCB001158.
dispersion Type
Geometric Coefficient of Variation
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
GEOMETRIC_MEAN
population Description
PK Population. Only participants with available date 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
Cmax 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
ng/mL

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Preserved source evidence · Not medical advice