Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ketoconazole · 2 trials · 1 indication
AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | There should be at least 14-day washout period between treatment A and B. |
| Name | Type | Description |
|---|---|---|
| crizotinib | DRUG | Treatment A: a single 150-mg dose of crizotinib will be administered in the fasted state on Day 1 as 1 × 50-mg and 1 × 100-mg Immediate Release Tablets. |
| ketoconazole | DRUG | Treatment B: 200 mg twice a day (approximately 12 hrs apart) doses of ketoconazole will be administered orally on an empty stomach from Day 1 to Day 16. |
Inclusion Criteria: * Healthy male and/or female of non-child bearing potential subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse...
Ketoconazole is an investigational small molecule being studied in healthy volunteers for drug interaction trials. It is used as a probe to assess the impact of multiple doses on the pharmacokinetics of other drugs, such as HCV-796 and crizotinib. It is not approved for any indication.
Ketoconazole is being developed by Pfizer, Inc. (NYSE: PFE). The company is conducting clinical trials to evaluate its effects on the pharmacokinetics of other drugs in healthy volunteers.
Ketoconazole is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, both involving healthy volunteers.
Ketoconazole has been studied in two completed Phase 1 trials: NCT00384917, which examined its impact on the pharmacokinetics of HCV-796, and NCT01149785, which estimated its effect on crizotinib pharmacokinetics. Both trials enrolled healthy volunteers.
No, ketoconazole is not the same as crizotinib. Ketoconazole is being studied as a potential inhibitor of drug-metabolizing enzymes, while crizotinib is a separate drug whose pharmacokinetics are being evaluated when co-administered with ketoconazole in a clinical trial.