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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03097016 | A Study to Assess the Pharmacokinetics of CC-122 in Subjects With Mild, Moderate, and Severe Renal Impairment | PHASE1 | COMPLETED | 48 | — | — | Mar 30, 2017 | Dec 23, 2017 | Apr 26, 2018 | 2 | United States |
Time to Observed maximum serum concentration (Cmax)
Observed maximum serum concentration (Cmax)
Area under the serum concentration-time curve calculated from time zero to the last measured time point
Area under the serum concentration-time curve calculated from time zero to infinity
Terminal elimination half-life
Apparent clearance of drug from serum when dosed orally
Apparent volume of distribution when dosed subcutaneously during the terminal phase
Renal Clearance
Amount of excretion
| Arm | Type | Description |
|---|---|---|
| Single oral dose of 3 mg CC-122 | EXPERIMENTAL | All subjects will receive one 3 mg CC-122 capsule the morning of Day 1 which will be administered in the fasted state. |
| Name | Type | Description |
|---|---|---|
| CC-122 | DRUG | All subjects will receive one 3 mg CC-122 capsule the morning of Day 1 which will be administered in the fasted state. |
Inclusion Criteria: * Each subject must satisfy all of the following criteria to be enrolled in the study: * Subject must understand and voluntarily sign an Informed Consent Form prior to any study-related assessments/procedures being conducted. * Subject is able to communicate with the Investigato...