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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-005879-12 | EudraCT Number |
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To evaluate the absorption, metabolism, and excretion of 86550-106 in healthy males.
The purpose of this study is to determine the absorption, metabolism, and excretion of a single oral dose of 400 mg (4x100 mg tablets) of INCB086550 followed by an oral dose solution of approximately 100 μCi (3.7 MBq) [14C]-INCB086550 and to characterize and determine the metabolites present in plasma, urine, and, where possible, feces in healthy male participants .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INCB086550 | Experimental | Participants will be administered INCB086550 orally, followed approximately 10 minutes later by an oral dose solution of radio labeled INCB086550. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INCB086550 | Drug | INCB086550 will be administered orally, followed approximately 10 minutes later by an oral dose solution of radio labeled INCB086550. |
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| Measure | Description | Time Frame |
|---|---|---|
| Total recovery of radioactivity from urine and feces. | To determine the route of elimination and mass balance of [14C]-INCB086550 following administration of a single oral dose of 400 mg of INCB086550 followed by an oral dose solution of approximately 100 μCi (3.7 MBq) [14C]-INCB086550. | Approximately 2 weeks |
| Percentage of total radioactive dose in Plasma, Urinary and Fecal Excretion | To characterize the metabolic profile and identify circulating and excreted metabolites of INCB086550 following administration of a single oral dose of 400 mg of INCB086550 followed by an oral dose solution of approximately 100 μCi (3.7 MBq) [14C]-INCB086550 using liquid chromatography with mass spectral detection. | Up to approximately 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| PK for plasma INCB086550: Cmax | Maximum Observed Plasma Concentration of INCB086550 to evaluate the PK of total radioactivity and parent compound following administration of a single oral dose of 400 mg of INCB086550 followed by an oral dose solution of approximately 100 μCi (3.7 MBq) [14C]-INCB086550. | Pre dose and Post dose on Day 1, Post dose Day 2, post dose Day 3, post dose Day 4, post dose Day 5 |
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Inclusion Criteria:
Exclusion Criteria:
History of clinically significant respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease.
Consumption of tobacco- or nicotine-containing products 72 hours before check-in (Day -1) until CRU discharge is not permitted.
Healthy male participants meeting all of the inclusion and none of the exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Jay Getsy | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Leeds Cru | Leeds | LS2 9LH | United Kingdom |
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| PK for plasma INCB086550: tmax | Time to reach maximum (peak) Plasma concentration of INCB086550 | Pre dose and Post dose on Day 1, Post dose Day 2, post dose Day 3, post dose Day 4, post dose Day 5 |
| PK for plasma INCB086550: AUC0-t | Area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration of INCB086550 | Pre dose and Post dose on Day 1, Post dose Day 2, post dose Day 3, post dose Day 4, post dose Day 5 |
| PK for plasma INCB086550: AUC0-∞ | area under the single-dose plasma concentration-time curve from Hour 0 to infinity of INCB086550 | Pre dose and Post dose on Day 1, Post dose Day 2, post dose Day 3, post dose Day 4, post dose Day 5 |
| PK for plasma INCB086550: t½ | AUC to the end of dosing period of INCB086550 | Pre dose and Post dose on Day 1, Post dose Day 2, post dose Day 3, post dose Day 4, post dose Day 5 |
| PK for plasma INCB086550: λz | Terminal elimination rate constant of INCB086550 | Pre dose and Post dose on Day 1, Post dose Day 2, post dose Day 3, post dose Day 4, post dose Day 5 |
| PK for plasma INCB086550: CL/F | Oral dose clearance of INCB086550 | Pre dose and Post dose on Day 1, Post dose Day 2, post dose Day 3, post dose Day 4, post dose Day 5 |
| PK for plasma INCB086550: Vz/F | Apparent oral dose volume of distribution of INCB086550 | Pre dose and Post dose on Day 1, Post dose Day 2, post dose Day 3, post dose Day 4, post dose Day 5 |
| PK for Urine INCB086550: Ae | Cumulative amount of unchanged drug excreted into the urine. Urine will be collected for the following intervals relative to study treatment administration: -12 to 0 hours (predose void [spot sample] only) and 0 to 6, 6 to 12, and 12 to 24 hours postdose and continuing in 24-hour intervals until discharge. | Pre dose and Post dose daily up to day 11, until study discharge |
| PK for urine INCB086550: CLR | Renal clearance of the drug from plasma. | Pre dose and Post dose daily up to day 11, until study discharge |
| PK for Urine INCB086550: fe | Fraction of the intravenously administered drug excreted into the urine | Pre dose and Post dose daily up to day 11, until study discharge |
| PK for whole blood and plasma total radioactivity: Cmax | Maximum Observed Plasma Concentration | Pre dose and poste dose Day 1, post dose Days 2, 3, 4, 5 and Days 6-11 as needed until study discharge |
| PK for whole blood and plasma total radioactivity: tmax | Time to reach maximum (peak) | Pre dose and post dose Day 1, post dose Days 2, 3, 4, 5 and Days 6-11 as needed until study discharge |
| PK for whole blood and plasma total radioactivity: t½ | To evaluate the PK of total radioactivity and parent compound following administration of a single oral dose of 400 mg of INCB086550 followed by an oral dose solution of approximately 100 μCi (3.7 MBq) [14C]-INCB086550. | Pre dose and post dose Day 1, post dose Days 2, 3, 4, 5 and Days 6-11 as needed until study discharge |
| PK for whole blood and plasma total radioactivity: AUC0-t | Area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration of INCB086550 | Pre dose and post dose Day 1, post dose Days 2, 3, 4, 5 and Days 6-11 as needed until study discharge |
| PK for whole blood and plasma total radioactivity: AUC0-∞ | To evaluate the PK of total radioactivity and parent compound following administration of a single oral dose of 400 mg of INCB086550 followed by an oral dose solution of approximately 100 μCi (3.7 MBq) [14C]-INCB086550. | Pre dose and post dose Day 1, post dose Days 2, 3, 4, 5 and Days 6-11 as needed until study discharge |
| Incidence of AEs, ECGs, vital signs, and clinical laboratory evaluation. | To evaluate the safety of a single oral dose of 400 mg of INCB086550 followed by an oral dose solution of approximately 100 μCi (3.7 MBq) [14C]-INCB086550. | up to approximately 3 months |