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This will be a Phase 1, open-label, single dose study of the Absorption, Metabolism, and Excretion of CYC065 in healthy male subjects.
Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the dose administration. Subjects will be admitted into the study site on Day -1 and be confined to the study site until at least Day 8 (168 hours post dose). On Day 1, subjects will receive a single oral dose of [14C]-CYC065. Subjects will be discharged if the following discharge criteria are met: plasma radioactivity levels below the limit of quantitation for 2 consecutive collections, ≥90% mass balance recovery, and ≤1% of the total radioactive dose is recovered in combined excreta (urine and feces) in 2 consecutive 24-hour periods. If discharge criteria are not met by Day 8, subjects will remain in the study site until all discharge criteria are met up to a maximum of Day 15.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Up to 8 subjects will be enrolled and studied as a single group | Experimental | The purpose of this study is to determine the absorption, metabolism, and excretion (AME) of [14C]CYC065 and to characterize and determine, where possible, the metabolites present in plasma, urine, and feces in healthy male subjects following a single oral administration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fadraciclib | Drug | Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-CYC065 Following a Single Oral Dose in Healthy Male Subjects |
|
| Measure | Description | Time Frame |
|---|---|---|
| The routes, rates of elimination, and mass balance | Total radioactivity from [14C]-CYC065 recovery (fet1t2) in urine and feces | Up to Day 15 |
| AUC for CYC065 in plasma | To characterize the PK of CYC065 and total radioactivity following administration of [14C]CYC065 to healthy subjects | Up to Day 15 |
| Cmax for CYC065 in plasma | To characterize the PK of CYC065 and total radioactivity following administration of [14C]CYC065 to healthy subjects | Up to Day 15 |
| Tmax for CYC065 in plasma | To characterize the PK of CYC065 and total radioactivity following administration of [14C]CYC065 to healthy subjects | Up to Day 15 |
| t½ for CYC065 in plasma | To characterize the PK of CYC065 and total radioactivity following administration of [14C]CYC065 to healthy subjects | Up to Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of CYC065 metabolites | To determine, where possible, the quantitative metabolite profiles in plasma, urine, and feces after [14C]CYC065 | Up to Day 15 |
| Incidence and severity of AEs |
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Inclusion Criteria:
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Labcorp Clinical Research Unit | Madison | Wisconsin | 53704 | United States |
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| ID | Term |
|---|---|
| C000621593 | CYC065 |
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To assess the safety and tolerability of [14C]CYC065 when administered to healthy subjects
| Up to Day 15 |