Good clinical practice The clinical studies reviewed in this evaluation were in compliance with published guidelines. Pharmacokinetics Studies providing pharmacokinetic data Table 1 shows the studies relating to each pharmacokinetic topic and the location of each study summary. Table 1: Submitted pharmacokinetic studies. Study Study Phase, design Number ID type population of subjects PK, Phase Ib, open-label Patients with Primary 22 safety, metastatic analysis CRPC Efficacy, Phase II, open-label, single Patients with 1-year 67 safety, arm analysis prostate PD, cancer PK Efficacy, Phase I-II open label, Japanese Primary 47 safety, uncontrolled, patients with analysis metastatic PK CRPC, with or without prior docetaxel None of the pharmacokinetic studies had deficiencies that excluded their results from consideration. Summary of pharmacokinetics The information in the following summary is derived from conventional pharmacokinetic studies unless otherwise stated. Pharmacokinetics in the target population The effect of co-administration of docetaxel and enzalutamide on docetaxel PK was assessed in study MDV3100-06. Concomitant administration was observed to not significantly affect the Cmax, AUClast or AUCmin of docetaxel (Table 2). Table 2: Comparison of plasma docetaxel pharmacokinetic parameters in treatment period 1 (pre-enzalutamide) and 2 (during enzalutamide).
Good clinical practice The clinical studies reviewed in this evaluation were in compliance with published guidelines. Pharmacokinetics Studies providing pharmacokinetic data Table 1 shows the studies relating to each pharmacokinetic topic and the location of each study summary. Table 1: Submitted pharmacokinetic studies. Study ID Study type Phase, design population Number of subjects PK, safety, Phase Ib, open-label Patients with metastatic CRPC Primary analysis 22 Efficacy, safety, PD, PK Phase II, open-label, single arm Patients with prostate cancer 1-year analysis 67 Efficacy, safety, PK Phase I-II open label, uncontrolled, Japanese patients with metastatic CRPC, with or without prior docetaxel Primary analysis 47 None of the pharmacokinetic studies had deficiencies that excluded their results from consideration. Summary of pharmacokinetics The information in the following summary is derived from conventional pharmacokinetic studies unless otherwise stated. Pharmacokinetics in the target population The effect of co-administration of docetaxel and enzalutamide on docetaxel PK was assessed in study MDV3100-06. Concomitant administration was observed to not significantly affect the Cmax, AUClast or AUCmin of docetaxel (Table 2). Table 2: Comparison of plasma docetaxel pharmacokinetic parameters in treatment period 1 (pre-enzalutamide) and 2 (during enzalutamide).
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