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| Name | Class |
|---|---|
| Celerion | INDUSTRY |
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This study will assess the absorption, metabolism, excretion, mass balance, safety, and tolerability of a single oral administration of [14C]-CTP-543 in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Product | Experimental | [14C]-CTP-543 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-CTP-543 | Drug | Single dose of radiolabeled CTP-543 (approximately 75 μCi) administered as an oral solution |
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| Measure | Description | Time Frame |
|---|---|---|
| Mass balance: Calculation of percent of total radioactivity recovered in urine | From time zero up to 96 hours post-dose following oral administration of [14C]-CTP-543 up to Day 15 | |
| Mass balance: Calculation of percent of total radioactivity recovered in feces | From time zero up to 96 hours post-dose following oral administration of [14C]-CTP-543 up to Day 15 | |
| CTP-543 PK: Cmax | Maximum plasma concentration | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose |
| CTP-543 PK: Tmax | Time for Cmax | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose |
| CTP-543 PK: t1/2 | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose | |
| CTP-543 PK: AUClast | Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration (Clast) | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose |
| CTP-543 PK: AUCinf | Area under the plasma concentration time profile from time 0 to infinity | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose |
| CTP-543 PK: CL/F | Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Number of adverse events, which are any untoward medical occurrence regardless of attribution to study drug in a participant who received study drug | Screening up to Day 15 |
| Number of Participants With Clinically Significant Change From Baseline in Heart Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Lincoln | Nebraska | 68502 | United States |
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| Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose |
| CTP-543 PK: Vz/F | Apparent volume of distribution following oral administration | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose |
| CTP-543 metabolite PK: Cmax | Maximum plasma concentration | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose |
| CTP-543 metabolite PK: Tmax | Time for Cmax | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose |
| CTP-543 metabolite PK: t1/2 | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose |
| CTP-543 metabolite PK: AUC0-last | Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration (Clast) | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose |
| CTP-543 metabolite PK: AUCinf | Area under the plasma concentration time profile from time 0 to infinity | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 96 hours post-dose |
| Total [14C]: urine | Total radioactivity excreted into the urine from time zero to the time of last measurable concentration following oral administration of [14C]-CTP-543 | Pre-dose up to 336 hours post-dose |
| Total [14C]: feces | Total radioactivity excreted into the feces from time zero to the time of last measurable concentration following oral administration of [14C]-CTP-543 | Pre-dose up to 336 hours post-dose |
| Total radioactivity in whole blood | Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose |
| Total radioactivity in plasma | Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose |
Heart rate measured in beats per minute (bpm) |
| Screening, Pre-dose, 2, 8, 48 hours post-dose |
| Number of Participants With Clinically Significant Change From Baseline in Blood Pressure | Blood pressure measured in millimeters of mercury (mmHg) | Screening, Pre-dose, 2, 8, 48 hours post-dose |
| Number of Participants With Clinically Significant Change From Baseline in Respiratory Rate | Respiratory rate measured in breaths per minute | Screening, Pre-dose, 2, 8, 48 hours post-dose |
| Number of Participants With Clinically Significant Change From Baseline in Temperature | Temperature measured in Celsius (°C) | Screening, Pre-dose, 2, 8, 48 hours post-dose |
| Number of Participants With Clinically Significant Change From Baseline in Hematology | Screening, Check-in, 8, 24 hours postdose |
| Number of Participants With Clinically Significant Change From Baseline in Serum Chemistry | Screening, Check-in, 8, 24 hours postdose |
| Number of Participants With Clinically Significant Change From Baseline in Coagulation | Screening, Check-in, 8, 24 hours postdose |
| Number of Participants With Clinically Significant Change From Baseline in Urinalysis | Screening, Check-in, 8, 24 hours postdose |
| Number of Participants With Clinically Significant Changes to the Physical Examination | Clinically significant changes to the physical examination | Screening up to Day 15 |
| Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram - P Wave | Screening, Pre-dose, 48 hours post-dose |
| Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram - QRS Complex | Screening, Pre-dose, 48 hours post-dose |
| Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram - QT Interval | Screening, Pre-dose, 48 hours post-dose |