PK in healthy General PK Single dose C0524T15 Absolute adults bioavailability of golimumab 100 mg SC in healthy Multi dose NND subjects Bioequivalence† Single dose NND NDD Food effect NA PK in special Target population § populations Single dose NND Multi-dose C0524T14 PK/PD of golimumab SC 100 mg 4 weeks and IV 2 mg/kg on Days 1 and 85 in patients with RA Hepatic impairment NND Renal impairment NND NND Elderly NND Other NND Genetic/ versus females NND NND related PK PK NND interactions Population Healthy subjects NND PK analyses Target population C0524T05 Trough PK for C0524T06 golimumab 50 mg C0524T09 and 100 mg in C0524T08 Phase 3 studies C0524T11 through week 104 Other NND NND: No new data were provided by the sponsor None of the PK studies had deficiencies that excluded their results from consideration. Evaluator’s overall conclusions on pharmacokinetics The kinetics and bioavailability of golimumab 100 mg SC are similar in patients compared with healthy volunteers and the % coefficient of variation (CV) was acceptable. Bioavailability of the 100 mg SC dose is comparable to the marketed 50 mg dose (if dose linearity was available in previous studies these data should be provided by the sponsor). Pharmacodynamics Table 2. Submitted pharmacodynamic (PD) studies PD Topic Subtopic Study ID Primary Aim of Study
PK in healthy adults General PK Single dose Multi dose C0524T15 NND Absolute bioavailability of golimumab 100 mg SC in healthy subjects Bioequivalence† Single dose NND NDD Food effect NA PK in special populations Target population § Single dose Multi-dose NND C0524T14 PK/PD of golimumab SC 100 mg 4 weeks and IV 2 mg/kg on Days 1 and 85 in patients with RA Hepatic impairment NND Renal impairment NND NND Elderly NND Other NND Genetic/ PK versus females NND NND PK interactions NND Population PK analyses Healthy subjects NND Target population C0524T05 C0524T06 C0524T09 C0524T08 C0524T11 Trough PK for golimumab 50 mg and 100 mg in Phase 3 studies through week 104 Other NND NND: No new data were provided by the sponsor None of the PK studies had deficiencies that excluded their results from consideration. Evaluator’s overall conclusions on pharmacokinetics The kinetics and bioavailability of golimumab 100 mg SC are similar in patients compared with healthy volunteers and the % coefficient of variation (CV) was acceptable. Bioavailability of the 100 mg SC dose is comparable to the marketed 50 mg dose (if dose linearity was available in previous studies these data should be provided by the sponsor). Pharmacodynamics Table 2. Submitted pharmacodynamic (PD) studies PD Topic Subtopic Study ID Primary Aim of Study related