4 results
- To evaluate the single-dose PK and pivotal bioequivalence of 3 compounds darunavir (DRV) 675 mg, FTC 200 mg, and tenofovir alafenamide (TAF) 10 mg in the presence of cobicistat (COBI)150 mg when administered as an fixed-dose combination (FDC) (D/C…
- To evaluate the single-dose PK and pivotal bioequivalence of 3 compounds darunavir (DRV) 675 mg, FTC 200 mg, and tenofovir alafenamide (TAF) 10 mg in the presence of cobicistat (COBI)150 mg when administered as an fixed-dose combination (FDC) (D/C…
Primary Objective:To evaluate the efficacy of ELX/TEZ/IVA in subjects 6 through 11 years of age with CF, heterozygous for F508del and a MF mutation (F/MF)Secondary Objectives:• To evaluate the PD of ELX/TEZ/IVA• To evaluate the safety of ELX/TEZ/IVA
To evaluate the effect of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) on glucose tolerance in CF subjects with impaired glucose tolerance (IGT) or CF related diabetes (CFRD)