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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04297124 | A Study to Evaluate the Metabolism and Excretion of [14C]-CC-90009 in Healthy Male Subjects | PHASE1 | COMPLETED | 8 | — | — | Mar 11, 2020 | Jun 4, 2021 | Dec 17, 2021 | 1 | United States |
Total \[14C\]-RA in whole blood, plasma, urine, and feces will be measured via LC-AMS
Total RA recovery will be computed as the sum of the cumulative excretion (as % dose) in urine and feces.
Ratio of total RA recovery in whole blood compared to in plasma
Observed maximum concentration
Area under the concentration
Time to Cmax.
Terminal elimination half-life
| Arm | Type | Description |
|---|---|---|
| [14C]-CC-90009 | EXPERIMENTAL | A single IV dose of 0.6 mg \[14C\]-CC-90009 containing approximately 2 µCi of radioactivity will be administered on Day 1 under fasted conditions. |
| Name | Type | Description |
|---|---|---|
| CC-90009 | DRUG | 0.6 mg \[ 14C\]-CC-90009 administered IV as a single dose |
| [14C] | RADIATION | A single dose of \[ 14C\]-CC-90009 will contain approximately 2 µCi of radioactivity. |
Inclusion Criteria: Subjects must satisfy the following criteria to be enrolled in the study: 1. Subject is ≥ 18 and ≤ 55 years of age at the time of signing the informed consent form (ICF). 2. Subject is male. 3. Subject must understand and voluntarily sign an ICF prior to any study-related asses...