and in accordance with applicable regulatory requirements and Boehringer Ingelheim (BI) standard operating procedures (SOPs). Pharmacokinetics Studies providing pharmacokinetic data Table 3 below shows the studies relating to each pharmacokinetic topic and the location of each study summary. Table 3. Submitted pharmacokinetic studies. PK topic Subtopic Study ID * PK in Safety, 1321.1 PKs of IV doses of idarucizumab and healthy tolerability, to explore the effect of different doses adults and PKs of idarucizumab administered on the steady state PK/PD of dabigatran 1321.2 PKs and PDs of idarucizumab and to establish the idarucizumab dose(s) effective in reversing prolongation of blood coagulation time. PK in Healthy 1321.5 PKs of idarucizumab and to explore special Japanese the effect of different trial of populations subjects idarucizumab administered at or close to the steady state of dabigatran Population Healthy 01-02-05 Characterise the of PK analyses subjects idarucizumab and its binding interaction with dabigatran and to provide PK/PD simulations * Indicates the primary aim of the study. None of the pharmacokinetic studies had deficiencies that excluded their results from consideration. Evaluator’s conclusions on pharmacokinetics Idarucizumab is a humanised monoclonal antibody fragment, which is administered via IV injection or infusion.
and in accordance with applicable regulatory requirements and Boehringer Ingelheim (BI) standard operating procedures (SOPs). Pharmacokinetics Studies providing pharmacokinetic data Table 3 below shows the studies relating to each pharmacokinetic topic and the location of each study summary. Table 3. Submitted pharmacokinetic studies. PK topic Subtopic Study ID * PK in healthy adults Safety, tolerability, and PKs 1321.1 PKs of IV doses of idarucizumab and to explore the effect of different doses of idarucizumab administered on the steady state PK/PD of dabigatran 1321.2 PKs and PDs of idarucizumab and to establish the idarucizumab dose(s) effective in reversing prolongation of blood coagulation time. PK in special populations Healthy Japanese subjects 1321.5 PKs of idarucizumab and to explore the effect of different of idarucizumab administered at or close to the steady state of dabigatran Population PK analyses Healthy subjects 01-02-05 Characterise the of idarucizumab and its binding interaction with dabigatran and to provide PK/PD simulations * Indicates the primary aim of the study. None of the pharmacokinetic studies had deficiencies that excluded their results from consideration. Evaluator’s conclusions on pharmacokinetics Idarucizumab is a humanised monoclonal antibody fragment, which is administered via IV injection or infusion. trial
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