NCT02903914 · OUTCOME

AUC0-tau 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: GEOMETRIC_MEAN
Unit: hours x ng/mL
Interval / dispersion: Geometric Coefficient of Variation
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

AUC0-tau was defined as the area under the concentration-time curve from dosing (time 0) of INCB001158 to the end of the dosing period.

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

Group	Source count
Part 2D: INCB001158 100 mg	5

Reported measurements

Capsule

Values in hours x ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Part 2D: INCB001158 100 mg	18000	0.22	Not reported	Not reported	Not reported

Tablet

Values in hours x ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Part 2D: INCB001158 100 mg	17200	0.28	Not reported	Not reported	Not reported

Source statistical analyses

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

ci Lower Limit
0.712
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
1.277
group Description
Tablet (test) versus Capsule (reference)
group Ids
OG000
non Inferiority Type
OTHER
p Value
0.7707
param Type
pairwise GMR
param Value
0.954
statistical Comment
1-factor ANOVA of log-transformed, dose-normalized data (factor = formulation)
statistical Method
ANOVA

Complete source fields

analyses

ci Lower Limit
0.712
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
1.277
group Description
Tablet (test) versus Capsule (reference)
group Ids
OG000
non Inferiority Type
OTHER
p Value
0.7707
param Type
pairwise GMR
param Value
0.954
statistical Comment
1-factor ANOVA of log-transformed, dose-normalized data (factor = formulation)
statistical Method
ANOVA

classes

categories
measurements
group Id
OG000
spread
0.22
value
18000
title
Capsule
categories
measurements
group Id
OG000
spread
0.28
value
17200
title
Tablet

denoms

counts
group Id
OG000
value
5
units
Participants

description

AUC0-tau was defined as the area under the concentration-time curve from dosing (time 0) of INCB001158 to the end of the dosing period.

dispersion Type

Geometric Coefficient of Variation

groups

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

GEOMETRIC_MEAN

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

AUC0-tau of INCB001158 for Capsules Versus Tablets for Part 2D to Assess the Effect of Formulation

type

SECONDARY

unit Of Measure

hours x ng/mL

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

Preserved source evidence · Not medical advice