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 drug being developed by Bristol-Myers Squibb Company (ticker: BMY). It is in Phase 1 clinical development. The specific disease indications being studied have not been disclosed. It is designed to target the protein GSPT1.
CC-90009 targets GSPT1, a protein. GSPT1 is involved in cellular processes, and CC-90009 is a small molecule designed to interact with this target. This mechanism is under investigation in early-stage clinical testing.
CC-90009 is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY. Bristol-Myers Squibb is a global biopharmaceutical company.
CC-90009 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 program includes one completed trial.
CC-90009 has been evaluated in one completed Phase 1 trial, NCT04297124, titled "A Study to Evaluate the Metabolism and Excretion of [14C]-CC-90009 in Healthy Male Subjects." This trial enrolled 8 healthy male volunteers in the United States and is now completed.