Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05817890 | Absorption, Metabolism, and Excretion of CYC065 in Healthy Male Subjects | EARLY_PHASE1 | COMPLETED | 8 | — | — | Mar 3, 2023 | May 22, 2024 | Sep 19, 2024 | 1 | United States |
Total radioactivity from \[14C\]-CYC065 recovery (fet1t2) in urine and feces
To characterize the PK of CYC065 and total radioactivity following administration of \[14C\]CYC065 to healthy subjects
To characterize the PK of CYC065 and total radioactivity following administration of \[14C\]CYC065 to healthy subjects
To characterize the PK of CYC065 and total radioactivity following administration of \[14C\]CYC065 to healthy subjects
To characterize the PK of CYC065 and total radioactivity following administration of \[14C\]CYC065 to healthy subjects
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| Fadraciclib | DRUG | Open-label Study of the Absorption, Metabolism, and Excretion of \[14C\]-CYC065 Following a Single Oral Dose in Healthy Male Subjects |
Inclusion Criteria: 1. Males, of any race, between 18 and 55 years of age, inclusive. 2. Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive, with a total body weight ≥50 kg. 3. In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram...