Trial Outcomes & Findings for A Study Assessing the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]INCB099280 in Healthy Male Participants (NCT NCT06309394)

NCT ID: NCT06309394

Last Updated: 2025-09-11

Results Overview

Radioactivity in urine and feces was reported as the percentage of the administered radioactivity excreted.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 5 participants
• Primary outcome timeframe: 264 hours in urine; 408 hours in feces
• Results posted on: 2025-09-11

Participant Flow

Participant milestones

Measure	INCB099280 400 mg + [14C]INCB099280 78.3 μCi Participants received a single dose of INCB099280 400 milligrams (mg) administered in tablet form (4 × 100-mg tablets) followed approximately 10 minutes later by an oral dose solution containing 78.3 microcuries (μCi) (2.9 megabecquerel \[MBq\]) of \[14C\]INCB099280 (not more than 97.2 μCi \[3.6 MBq\]).
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study Assessing the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]INCB099280 in Healthy Male Participants

Baseline characteristics by cohort

Measure	INCB099280 400 mg + [14C]INCB099280 78.3 μCi n=5 Participants Participants received a single dose of INCB099280 400 milligrams (mg) administered in tablet form (4 × 100-mg tablets) followed approximately 10 minutes later by an oral dose solution containing 78.3 microcuries (μCi) (2.9 megabecquerel \[MBq\]) of \[14C\]INCB099280 (not more than 97.2 μCi \[3.6 MBq\]).
Age, Continuous	44.2 years STANDARD_DEVIATION 5.81 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 264 hours in urine; 408 hours in feces

Population: Pharmacokinetic (PK)-Evaluable Population: all participants who received the study treatment and provided at least 1 postdose PK sample.

Radioactivity in urine and feces was reported as the percentage of the administered radioactivity excreted.

Outcome measures

Measure	INCB099280 400 mg + [14C]INCB099280 78.3 μCi n=5 Participants Participants received a single dose of INCB099280 400 milligrams (mg) administered in tablet form (4 × 100-mg tablets) followed approximately 10 minutes later by an oral dose solution containing 78.3 microcuries (μCi) (2.9 megabecquerel \[MBq\]) of \[14C\]INCB099280 (not more than 97.2 μCi \[3.6 MBq\]).
Total Recovery (Urine + Feces) of the Administered Radioactivity	83.2 percentage of radioactivity Interval 78.3 to 89.5

SECONDARY outcome

Timeframe: 0 hours (predose) and up to 24 hours post-dose

Population: PK-Evaluable Population

Plasma samples for metabolism investigations were obtained at 0, 1, 2, 4, 8, 12, 16, and 24 hours post-dose and were pooled across participants at each timepoint. TRPA=total radioactive peak area. The reported values are single measurements of pooled plasma or fecal samples; therefore, no statistical analysis is possible, and data have been reported with a measure type of "number."

Outcome measures

Measure	INCB099280 400 mg + [14C]INCB099280 78.3 μCi n=5 Participants Participants received a single dose of INCB099280 400 milligrams (mg) administered in tablet form (4 × 100-mg tablets) followed approximately 10 minutes later by an oral dose solution containing 78.3 microcuries (μCi) (2.9 megabecquerel \[MBq\]) of \[14C\]INCB099280 (not more than 97.2 μCi \[3.6 MBq\]).
Abundance of INCB099280 Detected in Plasma 1 hour post-dose	33.4 percentage of TRPA
Abundance of INCB099280 Detected in Plasma 2 hours post-dose	70.3 percentage of TRPA
Abundance of INCB099280 Detected in Plasma 4 hours post-dose	57.2 percentage of TRPA
Abundance of INCB099280 Detected in Plasma 8 hours post-dose	35.3 percentage of TRPA
Abundance of INCB099280 Detected in Plasma 12 hours post-dose	38.3 percentage of TRPA
Abundance of INCB099280 Detected in Plasma 16 hours post-dose	44.9 percentage of TRPA
Abundance of INCB099280 Detected in Plasma 24 hours post-dose	23.2 percentage of TRPA

SECONDARY outcome

Timeframe: 0 hours (predose) and up to 96 hours post-dose

Population: PK-Evaluable Population

Homogenized fecal samples from individual participants were pooled for each collection interval by taking a fixed percentage of the total amount excreted from each collection interval/participant. The reported values are single measurements of pooled plasma or fecal samples; therefore, no statistical analysis is possible, and data have been reported with a measure type of "number."

Outcome measures

Measure	INCB099280 400 mg + [14C]INCB099280 78.3 μCi n=5 Participants Participants received a single dose of INCB099280 400 milligrams (mg) administered in tablet form (4 × 100-mg tablets) followed approximately 10 minutes later by an oral dose solution containing 78.3 microcuries (μCi) (2.9 megabecquerel \[MBq\]) of \[14C\]INCB099280 (not more than 97.2 μCi \[3.6 MBq\]).
Abundance of INCB099280 Metabolites Detected in Feces INCB099280, 0 to 24 hours post-dose	1.98 percentage of total dosed radioactivity
Abundance of INCB099280 Metabolites Detected in Feces INCB099280, 24 to 48 hours post-dose	13.3 percentage of total dosed radioactivity
Abundance of INCB099280 Metabolites Detected in Feces INCB099280, 48 to 72 hours post-dose	36.6 percentage of total dosed radioactivity
Abundance of INCB099280 Metabolites Detected in Feces INCB099280, 72 to 96 hours post-dose	5.37 percentage of total dosed radioactivity
Abundance of INCB099280 Metabolites Detected in Feces M12, 0 to 24 hours post-dose	0 percentage of total dosed radioactivity
Abundance of INCB099280 Metabolites Detected in Feces M12, 24 to 48 hours post-dose	2.30 percentage of total dosed radioactivity
Abundance of INCB099280 Metabolites Detected in Feces M12, 48 to 72 hours post-dose	4.06 percentage of total dosed radioactivity
Abundance of INCB099280 Metabolites Detected in Feces M12, 72 to 96 hours post-dose	1.63 percentage of total dosed radioactivity

SECONDARY outcome

Timeframe: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

Population: PK-Evaluable Population

Cmax was defined as the maximum observed plasma or serum concentration of INCB099280.

Outcome measures

Measure	INCB099280 400 mg + [14C]INCB099280 78.3 μCi n=5 Participants Participants received a single dose of INCB099280 400 milligrams (mg) administered in tablet form (4 × 100-mg tablets) followed approximately 10 minutes later by an oral dose solution containing 78.3 microcuries (μCi) (2.9 megabecquerel \[MBq\]) of \[14C\]INCB099280 (not more than 97.2 μCi \[3.6 MBq\]).
Cmax of INCB099280	994 nanomolar Geometric Coefficient of Variation 90.8

SECONDARY outcome

Timeframe: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

Population: PK-Evaluable Population

tmax was defined as the time to the maximum concentration of INCB099280.

Outcome measures

Measure	INCB099280 400 mg + [14C]INCB099280 78.3 μCi n=5 Participants Participants received a single dose of INCB099280 400 milligrams (mg) administered in tablet form (4 × 100-mg tablets) followed approximately 10 minutes later by an oral dose solution containing 78.3 microcuries (μCi) (2.9 megabecquerel \[MBq\]) of \[14C\]INCB099280 (not more than 97.2 μCi \[3.6 MBq\]).
Tmax of INCB099280	4.0 hours Interval 2.0 to 4.2

SECONDARY outcome

Timeframe: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

Population: PK-Evaluable Population

AUC0-t was defined as the area under the steady-state plasma or serum concentration-time curve up to the last measurable concentration of INCB099280.

Outcome measures

Measure	INCB099280 400 mg + [14C]INCB099280 78.3 μCi n=5 Participants Participants received a single dose of INCB099280 400 milligrams (mg) administered in tablet form (4 × 100-mg tablets) followed approximately 10 minutes later by an oral dose solution containing 78.3 microcuries (μCi) (2.9 megabecquerel \[MBq\]) of \[14C\]INCB099280 (not more than 97.2 μCi \[3.6 MBq\]).
AUC0-t of INCB099280	11100 hours * nanomolar Geometric Coefficient of Variation 118

SECONDARY outcome

Timeframe: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

Population: PK-Evaluable Population

AUC0-∞ was defined as the area under the single-dose plasma or serum concentration-time curve extrapolated to time of infinity.

Outcome measures

Measure	INCB099280 400 mg + [14C]INCB099280 78.3 μCi n=5 Participants Participants received a single dose of INCB099280 400 milligrams (mg) administered in tablet form (4 × 100-mg tablets) followed approximately 10 minutes later by an oral dose solution containing 78.3 microcuries (μCi) (2.9 megabecquerel \[MBq\]) of \[14C\]INCB099280 (not more than 97.2 μCi \[3.6 MBq\]).
AUC0-∞ of INCB099280	11200 hours * nanomolar Geometric Coefficient of Variation 117

SECONDARY outcome

Timeframe: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

Population: PK-Evaluable Population

t½ was defined as the apparent terminal-phase disposition half-life of INCB099280.

Outcome measures

Measure	INCB099280 400 mg + [14C]INCB099280 78.3 μCi n=5 Participants Participants received a single dose of INCB099280 400 milligrams (mg) administered in tablet form (4 × 100-mg tablets) followed approximately 10 minutes later by an oral dose solution containing 78.3 microcuries (μCi) (2.9 megabecquerel \[MBq\]) of \[14C\]INCB099280 (not more than 97.2 μCi \[3.6 MBq\]).
t½ of INCB099280	14.8 hours Geometric Coefficient of Variation 17.9

SECONDARY outcome

Timeframe: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

Population: PK-Evaluable Population

CL/F was defined as the apparent oral dose clearance of INCB099280.

Outcome measures

Measure	INCB099280 400 mg + [14C]INCB099280 78.3 μCi n=5 Participants Participants received a single dose of INCB099280 400 milligrams (mg) administered in tablet form (4 × 100-mg tablets) followed approximately 10 minutes later by an oral dose solution containing 78.3 microcuries (μCi) (2.9 megabecquerel \[MBq\]) of \[14C\]INCB099280 (not more than 97.2 μCi \[3.6 MBq\]).
CL/F of INCB099280	46.9 liters per hour Geometric Coefficient of Variation 117

SECONDARY outcome

Timeframe: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

Population: PK-Evaluable Population

Vz/F was defined as the maximum observed plasma or serum concentration of INCB099280.

Outcome measures

Measure	INCB099280 400 mg + [14C]INCB099280 78.3 μCi n=5 Participants Participants received a single dose of INCB099280 400 milligrams (mg) administered in tablet form (4 × 100-mg tablets) followed approximately 10 minutes later by an oral dose solution containing 78.3 microcuries (μCi) (2.9 megabecquerel \[MBq\]) of \[14C\]INCB099280 (not more than 97.2 μCi \[3.6 MBq\]).
Vz/F of INCB099280	1000 liters Geometric Coefficient of Variation 91.3

SECONDARY outcome

Timeframe: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

Population: PK-Evaluable Population

Cmax was defined as the maximum observed concentration of total radioactivity in blood. Additional samples were collected every 24 hours until discharge (up to 264 hours).

Outcome measures

Measure	INCB099280 400 mg + [14C]INCB099280 78.3 μCi n=5 Participants Participants received a single dose of INCB099280 400 milligrams (mg) administered in tablet form (4 × 100-mg tablets) followed approximately 10 minutes later by an oral dose solution containing 78.3 microcuries (μCi) (2.9 megabecquerel \[MBq\]) of \[14C\]INCB099280 (not more than 97.2 μCi \[3.6 MBq\]).
Cmax of Total Radioactivity in Blood	1010 nanomolar Geometric Coefficient of Variation 61.1

SECONDARY outcome

Timeframe: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

Population: PK-Evaluable Population

tmax was defined as the time to the maximum concentration of total radioactivity in blood. Additional samples were collected every 24 hours until discharge (up to 264 hours).

Outcome measures

Measure	INCB099280 400 mg + [14C]INCB099280 78.3 μCi n=5 Participants Participants received a single dose of INCB099280 400 milligrams (mg) administered in tablet form (4 × 100-mg tablets) followed approximately 10 minutes later by an oral dose solution containing 78.3 microcuries (μCi) (2.9 megabecquerel \[MBq\]) of \[14C\]INCB099280 (not more than 97.2 μCi \[3.6 MBq\]).
Tmax of Total Radioactivity in Blood	4.0 hours Interval 2.0 to 4.2

SECONDARY outcome

Timeframe: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

Population: PK-Evaluable Population

AUC0-t was defined as the area under the steady-state plasma or serum concentration-time curve up to the last measurable concentration of total radioactivity in blood. Additional samples were collected every 24 hours until discharge (up to 264 hours).

Outcome measures

Measure	INCB099280 400 mg + [14C]INCB099280 78.3 μCi n=5 Participants Participants received a single dose of INCB099280 400 milligrams (mg) administered in tablet form (4 × 100-mg tablets) followed approximately 10 minutes later by an oral dose solution containing 78.3 microcuries (μCi) (2.9 megabecquerel \[MBq\]) of \[14C\]INCB099280 (not more than 97.2 μCi \[3.6 MBq\]).
AUC0-t of Total Radioactivity in Blood	14100 hours * nanomolar Geometric Coefficient of Variation 79.5

SECONDARY outcome

Timeframe: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

Population: PK-Evaluable Population. Analysis was not conducted as %AUCextrapolation ≥ 20%.

AUC0-∞ was defined as the area under the single-dose plasma or serum concentration-time curve extrapolated to time of infinity. Additional samples were collected every 24 hours until discharge (up to 264 hours).

Outcome measures

Measure	INCB099280 400 mg + [14C]INCB099280 78.3 μCi n=5 Participants Participants received a single dose of INCB099280 400 milligrams (mg) administered in tablet form (4 × 100-mg tablets) followed approximately 10 minutes later by an oral dose solution containing 78.3 microcuries (μCi) (2.9 megabecquerel \[MBq\]) of \[14C\]INCB099280 (not more than 97.2 μCi \[3.6 MBq\]).
AUC0-∞ of Total Radioactivity in Blood	37200 hours * nanomolar Geometric Coefficient of Variation 151

SECONDARY outcome

Timeframe: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

Population: PK-Evaluable Population. Analysis was not conducted as Rsq\_adjusted ≤ 0.7 and/or %AUCextrapolation ≥ 20%.

t½ was defined as the apparent terminal-phase disposition half-life of total radioactivity in blood. Additional samples were collected every 24 hours until discharge (up to 264 hours).

Outcome measures

Measure	INCB099280 400 mg + [14C]INCB099280 78.3 μCi n=5 Participants Participants received a single dose of INCB099280 400 milligrams (mg) administered in tablet form (4 × 100-mg tablets) followed approximately 10 minutes later by an oral dose solution containing 78.3 microcuries (μCi) (2.9 megabecquerel \[MBq\]) of \[14C\]INCB099280 (not more than 97.2 μCi \[3.6 MBq\]).
t½ of Total Radioactivity in Blood	36.1 hours Geometric Coefficient of Variation 321

SECONDARY outcome

Timeframe: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

Population: PK-Evaluable Population. Analysis was not conducted as %AUCextrapolation ≥ 20%.

CL/F was defined as the apparent oral dose clearance of total radioactivity in blood. Additional samples were collected every 24 hours until discharge (up to 264 hours).

Outcome measures

Measure	INCB099280 400 mg + [14C]INCB099280 78.3 μCi n=5 Participants Participants received a single dose of INCB099280 400 milligrams (mg) administered in tablet form (4 × 100-mg tablets) followed approximately 10 minutes later by an oral dose solution containing 78.3 microcuries (μCi) (2.9 megabecquerel \[MBq\]) of \[14C\]INCB099280 (not more than 97.2 μCi \[3.6 MBq\]).
CL/F of Total Radioactivity in Blood	14.2 liters per hour Geometric Coefficient of Variation 151

SECONDARY outcome

Timeframe: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

Population: PK-Evaluable Population. Analysis was not conducted as %AUCextrapolation ≥ 20%.

Vz/F was defined as the maximum observed plasma or serum concentration of total radioactivity in blood. Additional samples were collected every 24 hours until discharge (up to 264 hours).

Outcome measures

Measure	INCB099280 400 mg + [14C]INCB099280 78.3 μCi n=5 Participants Participants received a single dose of INCB099280 400 milligrams (mg) administered in tablet form (4 × 100-mg tablets) followed approximately 10 minutes later by an oral dose solution containing 78.3 microcuries (μCi) (2.9 megabecquerel \[MBq\]) of \[14C\]INCB099280 (not more than 97.2 μCi \[3.6 MBq\]).
Vz/F of Total Radioactivity in Blood	738 liters Geometric Coefficient of Variation 69.7

SECONDARY outcome

Timeframe: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

Population: PK-Evaluable Population

Cmax was defined as the maximum observed concentration of total radioactivity in plasma. Additional samples were collected every 24 hours until discharge (up to 264 hours).

Outcome measures

Measure	INCB099280 400 mg + [14C]INCB099280 78.3 μCi n=5 Participants Participants received a single dose of INCB099280 400 milligrams (mg) administered in tablet form (4 × 100-mg tablets) followed approximately 10 minutes later by an oral dose solution containing 78.3 microcuries (μCi) (2.9 megabecquerel \[MBq\]) of \[14C\]INCB099280 (not more than 97.2 μCi \[3.6 MBq\]).
Cmax of Total Radioactivity in Plasma	1450 nanomolar Geometric Coefficient of Variation 69.3

SECONDARY outcome

Timeframe: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

Population: PK-Evaluable Population

tmax was defined as the time to the maximum concentration of total radioactivity in plasma. Additional samples were collected every 24 hours until discharge (up to 264 hours).

Outcome measures

Measure	INCB099280 400 mg + [14C]INCB099280 78.3 μCi n=5 Participants Participants received a single dose of INCB099280 400 milligrams (mg) administered in tablet form (4 × 100-mg tablets) followed approximately 10 minutes later by an oral dose solution containing 78.3 microcuries (μCi) (2.9 megabecquerel \[MBq\]) of \[14C\]INCB099280 (not more than 97.2 μCi \[3.6 MBq\]).
Tmax of Total Radioactivity in Plasma	4.0 hours Interval 2.0 to 4.2

SECONDARY outcome

Timeframe: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

Population: PK-Evaluable Population

AUC0-t was defined as the area under the steady-state plasma or serum concentration-time curve up to the last measurable concentration of total radioactivity in plasma. Additional samples were collected every 24 hours until discharge (up to 264 hours).

Outcome measures

Measure	INCB099280 400 mg + [14C]INCB099280 78.3 μCi n=5 Participants Participants received a single dose of INCB099280 400 milligrams (mg) administered in tablet form (4 × 100-mg tablets) followed approximately 10 minutes later by an oral dose solution containing 78.3 microcuries (μCi) (2.9 megabecquerel \[MBq\]) of \[14C\]INCB099280 (not more than 97.2 μCi \[3.6 MBq\]).
AUC0-t of Total Radioactivity in Plasma	14100 hours * nanomolar Geometric Coefficient of Variation 126

SECONDARY outcome

Timeframe: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

Population: PK-Evaluable Population. Only participants with available data were analyzed.

AUC0-∞ was defined as the area under the single-dose plasma or serum concentration-time curve extrapolated to time of infinity. Additional samples were collected every 24 hours until discharge (up to 264 hours).

Outcome measures

Measure	INCB099280 400 mg + [14C]INCB099280 78.3 μCi n=5 Participants Participants received a single dose of INCB099280 400 milligrams (mg) administered in tablet form (4 × 100-mg tablets) followed approximately 10 minutes later by an oral dose solution containing 78.3 microcuries (μCi) (2.9 megabecquerel \[MBq\]) of \[14C\]INCB099280 (not more than 97.2 μCi \[3.6 MBq\]).
AUC0-∞ of Total Radioactivity in Plasma	18500 hours * nanomolar Geometric Coefficient of Variation 105

SECONDARY outcome

Timeframe: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

Population: PK-Evaluable Population. Only participants with available data were analyzed.

t½ was defined as the apparent terminal-phase disposition half-life of total radioactivity in plasma. Additional samples were collected every 24 hours until discharge (up to 264 hours).

Outcome measures

Measure	INCB099280 400 mg + [14C]INCB099280 78.3 μCi n=5 Participants Participants received a single dose of INCB099280 400 milligrams (mg) administered in tablet form (4 × 100-mg tablets) followed approximately 10 minutes later by an oral dose solution containing 78.3 microcuries (μCi) (2.9 megabecquerel \[MBq\]) of \[14C\]INCB099280 (not more than 97.2 μCi \[3.6 MBq\]).
t½ of Total Radioactivity in Plasma	8.88 hours Geometric Coefficient of Variation 57.6

SECONDARY outcome

Timeframe: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

Population: PK-Evaluable Population. Only participants with available data were analyzed.

CL/F was defined as the apparent oral dose clearance of total radioactivity in plasma. Additional samples were collected every 24 hours until discharge (up to 264 hours).

Outcome measures

Measure	INCB099280 400 mg + [14C]INCB099280 78.3 μCi n=5 Participants Participants received a single dose of INCB099280 400 milligrams (mg) administered in tablet form (4 × 100-mg tablets) followed approximately 10 minutes later by an oral dose solution containing 78.3 microcuries (μCi) (2.9 megabecquerel \[MBq\]) of \[14C\]INCB099280 (not more than 97.2 μCi \[3.6 MBq\]).
CL/F of Total Radioactivity in Plasma	28.5 liters per hour Geometric Coefficient of Variation 105

SECONDARY outcome

Timeframe: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)

Population: PK-Evaluable Population. Only participants with available data were analyzed.

Vz/F was defined as the maximum observed plasma or serum concentration of total radioactivity in plasma. Additional samples were collected every 24 hours until discharge (up to 264 hours).

Outcome measures

Measure	INCB099280 400 mg + [14C]INCB099280 78.3 μCi n=5 Participants Participants received a single dose of INCB099280 400 milligrams (mg) administered in tablet form (4 × 100-mg tablets) followed approximately 10 minutes later by an oral dose solution containing 78.3 microcuries (μCi) (2.9 megabecquerel \[MBq\]) of \[14C\]INCB099280 (not more than 97.2 μCi \[3.6 MBq\]).
Vz/F of Total Radioactivity in Plasma	365 liters Geometric Coefficient of Variation 40.4

SECONDARY outcome

Timeframe: up to Day 22

Population: Safety Population: all participants who received the study treatment

An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug.

Outcome measures

Measure	INCB099280 400 mg + [14C]INCB099280 78.3 μCi n=5 Participants Participants received a single dose of INCB099280 400 milligrams (mg) administered in tablet form (4 × 100-mg tablets) followed approximately 10 minutes later by an oral dose solution containing 78.3 microcuries (μCi) (2.9 megabecquerel \[MBq\]) of \[14C\]INCB099280 (not more than 97.2 μCi \[3.6 MBq\]).
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)	1 Participants

Adverse Events

INCB099280 400 mg + [14C]INCB099280 78.3 μCi

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	INCB099280 400 mg + [14C]INCB099280 78.3 μCi n=5 participants at risk Participants received a single dose of INCB099280 400 milligrams (mg) administered in tablet form (4 × 100-mg tablets) followed approximately 10 minutes later by an oral dose solution containing 78.3 microcuries (μCi) (2.9 megabecquerel \[MBq\]) of \[14C\]INCB099280 (not more than 97.2 μCi \[3.6 MBq\]).
Gastrointestinal disorders Diarrhoea	20.0% 1/5 • from signing of the Informed Consent Form until up to Day 22 Adverse events were analyzed in the Safety Population, comprised of all participants who received the study treatment.
Psychiatric disorders Anxiety	20.0% 1/5 • from signing of the Informed Consent Form until up to Day 22 Adverse events were analyzed in the Safety Population, comprised of all participants who received the study treatment.

Additional Information

Study Director

Incyte Corporation

Phone: 1-855-463-3463

Email: medinfo@incyte.com

Results disclosure agreements

• Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
• Publication restrictions are in place

Restriction type: OTHER