5 results
The primary objective of this study is to obtain clinical proof of principle that the addition of a PgP/BCRP inhibitor increases CNS concentrations of tyrosine kinase inhibitors by inhibition of drug efflux transporter function in the blood brain…
- To assess the pharmacokinetic profile of cysteamine base after single dose administration of the new sustained-release cysteamine bitartrate (PO-001) to healthy volunteers, in comparison with Cystagon® and Procysbi®.- To collect safety/…
Primary Objectives: To investigate the pharmacokinetic interaction of elexacaftor/tezacaftor/ivacaftor and tacrolimus in adult CF patients using tacrolimus after renal or liver transplantation by:- quantitating the effect of elexacaftor/tezacaftor/…
Primary objective (Parts A and B):To evaluate the long-term safety and tolerability of VX-445/TEZ/IVA in subjects with CF who are heterozygous for the F508del mutation and a gating (F/G) or residual function (F/RF) mutation.Secondary objectives (…
Primair eindpunt:Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis (CF) Who Are Homozygous or Heterozygous for the F508del Mutation.Secundair eindpunt:Evaluate the long-term efficacy of VX-…