Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CC-90009 · 1 trial · 1 indication
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...
CC-90009 is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial evaluating its metabolism and excretion in healthy male subjects. It is not approved for any indication.
CC-90009 is being developed by Bristol-Myers Squibb Company (ticker: BMY). The company is conducting clinical trials to evaluate the drug's properties in healthy volunteers.
CC-90009 is in Phase 1 clinical development. A Phase 1 study has been completed, and the drug remains investigational. It is not approved by regulatory authorities.
CC-90009 has one completed Phase 1 trial, NCT04297124, which evaluated the metabolism and excretion of [14C]-CC-90009 in healthy male subjects. The trial enrolled 8 participants in the United States.
CC-90009 and [14C]-CC-90009 are related compounds. The [14C]-labeled version is used in clinical trials to track the drug's metabolism and excretion, as seen in study NCT04297124. The unlabeled CC-90009 is the investigational drug being developed.