PK in healthy NP28989 General PK - Single dose * adults N/A - Multi-dose NP29040 Bioequivalence Single dose * †- N/A - Multi-dose PK in special NP28673 Target population §- Single dose populations NP28673 - Multi-dose * NP28761 * POPPK-1064536 Hepatic impairment (mild) POPPK-1064536 Renal impairment (mild to moderate) N/A Neonates/infants/children/ adolescents POPPK-1064536 Elderly AF-001JP Asian patients, similar to target * population but crizotinib-naïve, multi-dose. Genetic/ POPPK-1064536 versus females gender related PK POPPK-1064536 genetic variable Food effect NP28991 In healthy adults * NP28761 In target population AF-001JP (Japan) In with ALK+ve NSCLC PK NP28990 Posaconazole (CYP3A inhibitor) * – interactions healthy subjects NP29042 Rifampin (CYP3A inducer) healthy * – subjects NP28991 Esomeprazole (PPI) healthy * – subjects NP28673 Midazolam in ALK+ve NSCLC * – (substudy) patients Population N/A Healthy subjects PK analyses PK1064595 Target population (GastroPlus™)
PK in healthy adults General PK - Single dose NP28989 * - Multi-dose N/A Bioequivalence †- Single dose NP29040 * - Multi-dose N/A PK in special populations Target population §- Single dose NP28673 - Multi-dose NP28673 NP28761 * * Hepatic impairment (mild) POPPK-1064536 Renal impairment (mild to moderate) POPPK-1064536 Neonates/infants/children/ adolescents N/A Elderly POPPK-1064536 Asian patients, similar to target population but crizotinib-naïve, multi-dose. AF-001JP * Genetic/ gender related PK versus females POPPK-1064536 genetic variable POPPK-1064536 Food effect In healthy adults NP28991 * In target population NP28761 In with ALK+ve NSCLC AF-001JP (Japan) PK interactions Posaconazole (CYP3A inhibitor) – healthy subjects NP28990 * Rifampin (CYP3A inducer) – healthy subjects NP29042 * Esomeprazole (PPI) – healthy subjects NP28991 * Midazolam – in ALK+ve NSCLC patients NP28673 (substudy) * Population PK analyses Healthy subjects N/A Target population PK1064595 (GastroPlus™)
auspar-alectinib-hydrochloride-171127-cer.docx