Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Quinidine · 1 trial · 1 indication
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...
Quinidine is a small molecule drug being developed by Bristol-Myers Squibb Company (BMY). It is currently in Phase 1 clinical development. The drug has been studied in a completed clinical trial involving healthy male volunteers.
Quinidine has been studied for use in healthy volunteers. The completed clinical trial, NCT01712828, evaluated the effect of P-glycoprotein inhibition on lenalidomide pharmacokinetics in healthy males. Quinidine was used as a P-glycoprotein inhibitor in this study.
Quinidine is used as a P-glycoprotein inhibitor. In the clinical trial NCT01712828, it was administered to healthy males to assess its effect on the pharmacokinetics of lenalidomide, a drug that is a substrate of P-glycoprotein.
Quinidine is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY. The company is conducting clinical research on this small molecule drug.
Quinidine is in Phase 1 clinical development. The drug has one completed Phase 1 trial, NCT01712828, which enrolled 31 healthy male participants in the United States. There are no active trials currently listed for Quinidine.
Quinidine has been studied in one clinical trial, NCT01712828, titled 'Effect of P-glycoprotein Inhibition on Lenalidomide Pharmacokinetics in Healthy Males.' This Phase 1 trial was completed and enrolled 31 healthy male volunteers aged 18 years and older in the United States.