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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03742882 | A Study to Assess the Pharmacokinetics of CC-90001 in Subjects With Mild, Moderate, and Severe Hepatic Impairment Compared With Healthy Subjects | PHASE1 | COMPLETED | 40 | — | — | Dec 6, 2018 | Jun 10, 2019 | Jul 27, 2020 | 4 | United States |
Estimation of AUC calculated from time zero to the last measured time point
Estimation of AUC calculated from time zero to infinity
Estimation of observed maximum plasma concentration
Estimation of time to Cmax
Estimation of terminal elimination half-life
Estimation of apparent clearance of drug from plasma after extravascular administration
Estimation of apparent volume of distribution during the terminal phase
| Arm | Type | Description |
|---|---|---|
| Administration of CC-90001 | EXPERIMENTAL | Single oral dose of 200 mg of CC-90001 |
| Name | Type | Description |
|---|---|---|
| CC-90001 | DRUG | CC-90001 |
Inclusion Criteria: 1. Subject must understand and voluntarily sign an Informed Consent Form (ICF) prior to any study-related assessments/procedures being conducted. 2. Subject is willing and able to adhere to the study visit schedule and other protocol requirements, including the restrictions. 3. ...