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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05389722 | A Study to Assess the Drug Levels of CC-92480 After Coadministration With Rifampin and Itraconazole, and the Drug Levels of Digoxin and Rosuvastatin After Coadministration With CC-92480 in Healthy Participants | PHASE1 | COMPLETED | 24 | — | — | Jun 9, 2022 | Nov 12, 2022 | Apr 19, 2023 | 1 | United States |
| NCT04839809 | A Study to Assess Safety, Tolerability, and Pharmacokinetics of CC-92480 Formulations in Healthy Adult Participants | PHASE1 | COMPLETED | 40 | — | — | Jan 19, 2021 | Oct 8, 2021 | Dec 10, 2021 | 1 | United States |
| NCT04560738 | A Study to Evaluate the Metabolism and Excretion of [14C]-CC-92480 in Healthy Male Participants | PHASE1 | COMPLETED | 8 | — | — | Oct 15, 2020 | May 13, 2021 | Nov 29, 2021 | 1 | United States |
Maximum plasma concentration of drug
Time to maximum plasma concentration
Area under the plasma concentration-time curve from time zero to infinity
Area under the plasma concentration-time curve from time zero to the last observable concentration
Terminal elimination half-life
Apparent total plasma clearance
Apparent volume of distribution
Lag time between time of administration and start of absorption
Maximum plasma concentration of drug
Ratio of maximum plasma concentration of drug
Area under the plasma concentration-time curve from time zero to infinity
Ratio of area under the plasma concentration-time curve from time zero to infinity
Area under the plasma concentration-time curve from time zero to the last observable concentration
Area under the plasma concentration-time curve from time zero to the last observable concentration
Time to maximum plasma concentration
Terminal elimination half-life
Apparent total plasma clearance
Apparent volume of distribution
Lag time between time of administration and start of absorption
The total recovery of radioactivity (RA) will be computed as the sum of the cumulative excretion (as % dose) in urine and feces (and vomit, if applicable).
Time to reach maximum total radioactivity or concentration of CC-92480 and its metabolites
Maximum total radioactivity or concentration of CC-92480 and its metabolites
Area under the concentration-time curve from time zero to the last measured time point
Area under the concentration-time curve from time zero extrapolated to infinite time
Apparent oral clearance
Apparent volume of distribution
Terminal elimination half-life
The percentage of the administered dose attributed to CC-92480 and its metabolites in urine and feces
| Arm | Type | Description |
|---|---|---|
| Part 1 | EXPERIMENTAL | - |
| Part 2 | EXPERIMENTAL | - |
| Part 3 | EXPERIMENTAL | - |
| CC-92480-02 (Formulation A) with Placebo | EXPERIMENTAL | CC-92480-02 (Formulation A) or matching placebo to be administered orally under fasted conditions. |
| CC-92480 (Formulation B)- fasted condition | EXPERIMENTAL | A single oral dose of CC-92480 (Formulation B) administered under fasted conditions. |
| CC-92480-02 (Formulation A) - fasted condition | EXPERIMENTAL | A single oral dose of CC-92480-02 (Formulation A) administered under fasted conditions. |
| CC-92480 (Formulation B) - Low-fat meal | EXPERIMENTAL | A single oral dose of CC-92480 (Formulation B) administered under fed conditions (low-fat meal). |
| CC-92480-02 (Formulation A) - high-fat meal | EXPERIMENTAL | A single oral dose of CC-92480-02 (Formulation A) administered under fed conditions (high-fat meal). |
| Administration of [14C]-CC-92480 | EXPERIMENTAL | \[14C\]-CC-92480 will be administered as an oral solution. A single oral dose of \[14C\]-CC-92480, containing approximately 2 μCi of radioactivity, will be administered on Day 1 under fasted conditions. |
| Name | Type | Description |
|---|---|---|
| CC-92480 | DRUG | Specified dose on specified days |
| Rifampin | DRUG | Specified dose on specified days |
| Itraconazole | DRUG | Specified dose on specified days |
| Digoxin | DRUG | Specified dose on specified days |
| Rosuvastatin | DRUG | Specified dose on specified days |
| Placebo | OTHER | Oral |
| [14C]-CC-92480 | DRUG | Oral |
Inclusion Criteria: * Must have a body mass index between 18 and 33 kg/m2 (inclusive) * Adult female of nonchildbearing potential or male, any race or ethnicity, and in good health as determined by the medical history, physical exam, vital signs, 12-lead electrocardiogram, and clinical laboratory a...