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This study is being conducted to assess the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]INCB099280 in Healthy Male Participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INCB099280 | Experimental | Participants will be administered INCB099280 tablet orally, followed approximately 10 minutes later by an oral dose solution of radiolabeled INCB099280. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INCB099280 | Drug | INCB099280 will be administered orally, followed approximately 10 minutes later by an oral dose solution of radiolabeled INCB099280. |
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| Measure | Description | Time Frame |
|---|---|---|
| Total Recovery (Urine + Feces) of the Administered Radioactivity | Radioactivity in urine and feces was reported as the percentage of the administered radioactivity excreted. | 264 hours in urine; 408 hours in feces |
| Measure | Description | Time Frame |
|---|---|---|
| Abundance of INCB099280 Detected in Plasma | 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." |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined Inclusion/Exclusion Criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Incyte Medical | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences Ltd | Nottingham | NG11 6JS | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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]). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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]). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Recovery (Urine + Feces) of the Administered Radioactivity | Radioactivity in urine and feces was reported as the percentage of the administered radioactivity excreted. | Pharmacokinetic (PK)-Evaluable Population: all participants who received the study treatment and provided at least 1 postdose PK sample. | Posted | Median | Full Range | percentage of radioactivity | 264 hours in urine; 408 hours in feces |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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]). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Incyte Corporation | 1-855-463-3463 | medinfo@incyte.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 25, 2024 | Jun 2, 2025 | Prot_SAP_000.pdf |
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| 0 hours (predose) and up to 24 hours post-dose |
| Abundance of INCB099280 Metabolites Detected in Feces | 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." | 0 hours (predose) and up to 96 hours post-dose |
| Cmax of INCB099280 | Cmax was defined as the maximum observed plasma or serum concentration of INCB099280. | 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) |
| Tmax of INCB099280 | tmax was defined as the time to the maximum concentration of INCB099280. | 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) |
| AUC0-t of INCB099280 | 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. | 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) |
| AUC0-∞ of INCB099280 | AUC0-∞ was defined as the area under the single-dose plasma or serum concentration-time curve extrapolated to time of infinity. | 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) |
| t½ of INCB099280 | t½ was defined as the apparent terminal-phase disposition half-life of INCB099280. | 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) |
| CL/F of INCB099280 | CL/F was defined as the apparent oral dose clearance of INCB099280. | 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) |
| Vz/F of INCB099280 | Vz/F was defined as the maximum observed plasma or serum concentration of INCB099280. | 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) |
| Cmax of Total Radioactivity in Blood | 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). | 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) |
| Tmax of Total Radioactivity in Blood | 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). | 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) |
| AUC0-t of Total Radioactivity in Blood | 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). | 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) |
| AUC0-∞ of Total Radioactivity in Blood | 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). | 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) |
| t½ of Total Radioactivity in Blood | 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). | 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) |
| CL/F of Total Radioactivity in Blood | 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). | 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) |
| Vz/F of Total Radioactivity in Blood | 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). | 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) |
| Cmax of Total Radioactivity in Plasma | 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). | 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) |
| Tmax of Total Radioactivity in Plasma | 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). | 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) |
| AUC0-t of Total Radioactivity in Plasma | 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). | 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) |
| AUC0-∞ of Total Radioactivity in Plasma | 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). | 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) |
| t½ of Total Radioactivity in Plasma | 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). | 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) |
| CL/F of Total Radioactivity in Plasma | 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). | 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) |
| Vz/F of Total Radioactivity in Plasma | 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). | 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) |
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | 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. | up to Day 22 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
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| Secondary | Abundance of INCB099280 Detected in Plasma | 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." | PK-Evaluable Population | Posted | Number | percentage of TRPA | 0 hours (predose) and up to 24 hours post-dose |
|
|
|
| Secondary | Abundance of INCB099280 Metabolites Detected in Feces | 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." | PK-Evaluable Population | Posted | Number | percentage of total dosed radioactivity | 0 hours (predose) and up to 96 hours post-dose |
|
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| Secondary | Cmax of INCB099280 | Cmax was defined as the maximum observed plasma or serum concentration of INCB099280. | PK-Evaluable Population | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomolar | 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) |
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| Secondary | Tmax of INCB099280 | tmax was defined as the time to the maximum concentration of INCB099280. | PK-Evaluable Population | Posted | Median | Full Range | hours | 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) |
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| Secondary | AUC0-t of INCB099280 | 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. | PK-Evaluable Population | Posted | Geometric Mean | Geometric Coefficient of Variation | hours * nanomolar | 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) |
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| Secondary | AUC0-∞ of INCB099280 | AUC0-∞ was defined as the area under the single-dose plasma or serum concentration-time curve extrapolated to time of infinity. | PK-Evaluable Population | Posted | Geometric Mean | Geometric Coefficient of Variation | hours * nanomolar | 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) |
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| Secondary | t½ of INCB099280 | t½ was defined as the apparent terminal-phase disposition half-life of INCB099280. | PK-Evaluable Population | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | 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) |
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| Secondary | CL/F of INCB099280 | CL/F was defined as the apparent oral dose clearance of INCB099280. | PK-Evaluable Population | Posted | Geometric Mean | Geometric Coefficient of Variation | liters per hour | 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) |
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| Secondary | Vz/F of INCB099280 | Vz/F was defined as the maximum observed plasma or serum concentration of INCB099280. | PK-Evaluable Population | Posted | Geometric Mean | Geometric Coefficient of Variation | liters | 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) |
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| Secondary | Cmax of Total Radioactivity in Blood | 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). | PK-Evaluable Population | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomolar | 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) |
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| Secondary | Tmax of Total Radioactivity in Blood | 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). | PK-Evaluable Population | Posted | Median | Full Range | hours | 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) |
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| Secondary | AUC0-t of Total Radioactivity in Blood | 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). | PK-Evaluable Population | Posted | Geometric Mean | Geometric Coefficient of Variation | hours * nanomolar | 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) |
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| Secondary | AUC0-∞ of Total Radioactivity in Blood | 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). | PK-Evaluable Population. Analysis was not conducted as %AUCextrapolation ≥ 20%. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours * nanomolar | 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) |
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| Secondary | t½ of Total Radioactivity in Blood | 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). | PK-Evaluable Population. Analysis was not conducted as Rsq_adjusted ≤ 0.7 and/or %AUCextrapolation ≥ 20%. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | 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) |
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| Secondary | CL/F of Total Radioactivity in Blood | 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). | PK-Evaluable Population. Analysis was not conducted as %AUCextrapolation ≥ 20%. | Posted | Geometric Mean | Geometric Coefficient of Variation | liters per hour | 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) |
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| Secondary | Vz/F of Total Radioactivity in Blood | 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). | PK-Evaluable Population. Analysis was not conducted as %AUCextrapolation ≥ 20%. | Posted | Geometric Mean | Geometric Coefficient of Variation | liters | 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) |
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| Secondary | Cmax of Total Radioactivity in Plasma | 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). | PK-Evaluable Population | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomolar | 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) |
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| Secondary | Tmax of Total Radioactivity in Plasma | 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). | PK-Evaluable Population | Posted | Median | Full Range | hours | 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) |
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| Secondary | AUC0-t of Total Radioactivity in Plasma | 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). | PK-Evaluable Population | Posted | Geometric Mean | Geometric Coefficient of Variation | hours * nanomolar | 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) |
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| Secondary | AUC0-∞ of Total Radioactivity in Plasma | 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). | PK-Evaluable Population. Only participants with available data were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours * nanomolar | 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) |
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| Secondary | t½ of Total Radioactivity in Plasma | 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). | PK-Evaluable Population. Only participants with available data were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | 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) |
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| Secondary | CL/F of Total Radioactivity in Plasma | 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). | PK-Evaluable Population. Only participants with available data were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | liters per hour | 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) |
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| Secondary | Vz/F of Total Radioactivity in Plasma | 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). | PK-Evaluable Population. Only participants with available data were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | liters | 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) |
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| Secondary | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | 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. | Safety Population: all participants who received the study treatment | Posted | Count of Participants | Participants | up to Day 22 |
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|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 1 |
| 5 |
| Anxiety | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
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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.
| Title | Measurements |
|---|---|
|
| 8 hours post-dose |
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| 12 hours post-dose |
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| 16 hours post-dose |
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| 24 hours post-dose |
|
| Title | Measurements |
|---|---|
|
| INCB099280, 72 to 96 hours post-dose |
|
| M12, 0 to 24 hours post-dose |
|
| M12, 24 to 48 hours post-dose |
|
| M12, 48 to 72 hours post-dose |
|
| M12, 72 to 96 hours post-dose |
|