NCT02903914 · OUTCOME

AUC 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: hours x 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

AUC was defined as the area under the concentration-time curve 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

Group	Source count
Part 1A: INCB001158 50 mg	6
Part 1A: INCB001158 75 mg	7
Part 1A: INCB001158 100 mg	7
Part 1A: INCB001158 150 mg	6

Reported measurements

Fasted

Analysis denominator · Participants

Group	Source count
Part 1A: INCB001158 50 mg	5
Part 1A: INCB001158 75 mg	5
Part 1A: INCB001158 100 mg	7
Part 1A: INCB001158 150 mg	6

Values in hours x ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Part 1A: INCB001158 50 mg	6030	0.26	Not reported	Not reported	Not reported
Part 1A: INCB001158 75 mg	11900	0.37	Not reported	Not reported	Not reported
Part 1A: INCB001158 100 mg	13100	0.31	Not reported	Not reported	Not reported
Part 1A: INCB001158 150 mg	22100	0.29	Not reported	Not reported	Not reported

Fed

Analysis denominator · Participants

Group	Source count
Part 1A: INCB001158 50 mg	6
Part 1A: INCB001158 75 mg	6
Part 1A: INCB001158 100 mg	6
Part 1A: INCB001158 150 mg	3

Values in hours x ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Part 1A: INCB001158 50 mg	55550	0.44	Not reported	Not reported	Not reported
Part 1A: INCB001158 75 mg	11000	0.27	Not reported	Not reported	Not reported
Part 1A: INCB001158 100 mg	13100	0.35	Not reported	Not reported	Not reported
Part 1A: INCB001158 150 mg	16400	0.89	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
0.620
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
1.363
group Description
Fed versus Fasted
group Ids
OG000
non Inferiority Type
OTHER
p Value
0.7050
param Type
pairwise GMR
param Value
0.920
statistical Comment
1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)
statistical Method
ANOVA
ci Lower Limit
0.658
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
1.310
group Description
Fed versus Fasted
group Ids
OG001
non Inferiority Type
OTHER
p Value
0.7030
param Type
pairwise GMR
param Value
0.929
statistical Comment
1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)
statistical Method
ANOVA
ci Lower Limit
0.725
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
1.377
group Description
Fed versus Fasted
group Ids
OG002
non Inferiority Type
OTHER
p Value
0.9952
param Type
pairwise GMR
param Value
0.999
statistical Comment
1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)
statistical Method
ANOVA
ci Lower Limit
0.394
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
1.397
group Description
Fed versus Fasted
group Ids
OG003
non Inferiority Type
OTHER
p Value
0.4012
param Type
pairwise GMR
param Value
0.742
statistical Comment
1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)
statistical Method
ANOVA

Complete source fields

analyses

ci Lower Limit
0.620
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
1.363
group Description
Fed versus Fasted
group Ids
OG000
non Inferiority Type
OTHER
p Value
0.7050
param Type
pairwise GMR
param Value
0.920
statistical Comment
1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)
statistical Method
ANOVA
ci Lower Limit
0.658
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
1.310
group Description
Fed versus Fasted
group Ids
OG001
non Inferiority Type
OTHER
p Value
0.7030
param Type
pairwise GMR
param Value
0.929
statistical Comment
1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)
statistical Method
ANOVA
ci Lower Limit
0.725
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
1.377
group Description
Fed versus Fasted
group Ids
OG002
non Inferiority Type
OTHER
p Value
0.9952
param Type
pairwise GMR
param Value
0.999
statistical Comment
1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)
statistical Method
ANOVA
ci Lower Limit
0.394
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
1.397
group Description
Fed versus Fasted
group Ids
OG003
non Inferiority Type
OTHER
p Value
0.4012
param Type
pairwise GMR
param Value
0.742
statistical Comment
1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)
statistical Method
ANOVA

classes

categories
measurements
group Id
OG000
spread
0.26
value
6030
group Id
OG001
spread
0.37
value
11900
group Id
OG002
spread
0.31
value
13100
group Id
OG003
spread
0.29
value
22100
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
5
group Id
OG002
value
7
group Id
OG003
value
6
units
Participants
title
Fasted
categories
measurements
group Id
OG000
spread
0.44
value
55550
group Id
OG001
spread
0.27
value
11000
group Id
OG002
spread
0.35
value
13100
group Id
OG003
spread
0.89
value
16400
denoms
counts
group Id
OG000
value
6
group Id
OG001
value
6
group Id
OG002
value
6
group Id
OG003
value
3
units
Participants
title
Fed

denoms

counts
group Id
OG000
value
6
group Id
OG001
value
7
group Id
OG002
value
7
group Id
OG003
value
6
units
Participants

description

AUC was defined as the area under the concentration-time curve of INCB001158.

dispersion Type

Geometric Coefficient of Variation

groups

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
description
INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
id
OG001
title
Part 1A: INCB001158 75 mg
description
INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
id
OG002
title
Part 1A: INCB001158 100 mg
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

AUC 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 x ng/mL

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

Preserved source evidence · Not medical advice