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NCT02903914 · OUTCOME

Tmax of INCB001158 for Capsules Versus Tablets for Part 2D to Assess the Effect of Formulation

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
Tablet: Cycle 1 Day 15 (Tablet) and Cycle 2 Day 1 (Capsule): predose; 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose

What was measured

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

Analysis population: PK Population

Groups in this outcome

Part 2D: INCB001158 100 mg

INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors. Participants enrolled in Part 2D received INCB001158 tablets from C1D1 to C1D15, and then switched to INCB001158 capsules starting on C1D16 onwards.

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 2D: INCB001158 100 mg5

Reported measurements

Capsule
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 2D: INCB001158 100 mg3.8Not reported1.86.0Not reported
Tablet
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 2D: INCB001158 100 mg3.8Not reported1.94.0Not reported

Source statistical analyses

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

  1. group Description
    Tablet (test) versus Capsule (reference)
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    0.7540
    statistical Method
    Wilcoxon (Mann-Whitney)
Complete source fields
analyses
  1. group Description
    Tablet (test) versus Capsule (reference)
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    0.7540
    statistical Method
    Wilcoxon (Mann-Whitney)
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.8
        upper Limit
        6.0
        value
        3.8
    title
    Capsule
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.9
        upper Limit
        4.0
        value
        3.8
    title
    Tablet
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    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 100 mg BID in participants with advanced/metastatic solid tumors. Participants enrolled in Part 2D received INCB001158 tablets from C1D1 to C1D15, and then switched to INCB001158 capsules starting on C1D16 onwards.
    id
    OG000
    title
    Part 2D: INCB001158 100 mg
param Type
MEDIAN
population Description
PK Population
reporting Status
POSTED
time Frame
Tablet: Cycle 1 Day 15 (Tablet) and Cycle 2 Day 1 (Capsule): predose; 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose
title
Tmax of INCB001158 for Capsules Versus Tablets for Part 2D to Assess the Effect of Formulation
type
SECONDARY
unit Of Measure
hours

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

Preserved source evidence · Not medical advice