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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01712828 | Effect of P-glycoprotein Inhibition on Lenalidomide Pharmacokinetics in Healthy Males | PHASE1 | COMPLETED | 31 | — | — | Oct 1, 2012 | Jan 1, 2013 | Nov 8, 2019 | 1 | United States |
Area under the plasma concentration-time curve from time zero to 24 hours post dose
Maximum observed plasma concentration
Time to maximum observed plasma concentration
Area under the plasma concentration-time curve from time zero to time t, where t is the last measurable time point
Area under the plasma concentration-time curve from time zero extrapolated to infinity
Estimate of the terminal elimination half-life in plasma
Area under the plasma concentration-time curve from time zero to 24 hours post dose
Maximum observed plasma concentration
Time to maximum observed plasma concentration
Area under the plasma concentration-time curve from time zero to time t, where t is the last measurable time point
| Arm | Type | Description |
|---|---|---|
| Lenalidomide plus Quinidine | EXPERIMENTAL | - |
| Lenalidomide plusTemsirolimus and Diphenhydramine | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Lenalidomide | DRUG | 25 mg Lenalidomide capsule will be administered orally once in the first period, and once with Quinidine in the second period |
| Quinidine | DRUG | 300 mg of Quinidine will be administered orally every 12 hours for 1 day followed by 600 mg of Quinidine administered orally every 12 hours for the next 4 consecutive days |
| Temsirolimus | DRUG | 25 mg/mL injection of Temsirolimus will be given directly into the vein over 30 minutes once in the second period and once with Lenalidomide in the third period. |
| Diphenhydramine | DRUG | Just before Temsirolimus is given, 25 mg of Diphenhydramine (Benadryl) will be given directly into the vein to decrease chances of an allergic reaction to Temsirolimus. |
Inclusion Criteria: * Must understand and voluntarily sign a written informed consent form prior to any study-related procedures being performed. * Must be able to communicate with the investigator, understand and comply with the requirements of the study, and agree to adhere to restrictions and ex...