9 results
To validate the use of single urethral sensor catheter in demonstrating urethral pressure variations during filling cystometryIncidence of significant urethral pressure variations during urodynamic filling phase measured with three urethral sensor…
The purpose of Part A is to investigate how safe the study compound VX-152 is and how well the study compound is tolerated. The study will also investigate how quickly and to what extent the compound is absorbed into and eliminated from the body (…
To evaluate the long-term safety and tolerability of elexacaftor(ELX)/tezacaftor (TEZ)/ivacaftor (IVA)
The primary objective of this study is to evaluate the effect of multiple doses of azithromycin, clarithromycin and ritonavir on the pharmacokinetics, safety and tolerability of a single oral 150 mg dose of ivacaftor in healthy controls and in…
In this study, we want to investigate the effect of the change in co-medication from lumacaftor to tezacaftor on the kinetics and exposure levels of ivacaftor described by the through concentrationsPrimary Objective: - the through concentration of…
Primary Objective:To verify the accuracy and performance of the GlycostatTM System including its ability to secure good glycemic control by means of its algorithm. The accuracy of Glycostat, expressed by MARD (Mean Absolute Relative Difference), the…
Main objective:Part ATo evaluate the long-term safety and tolerability of VX-661 in combination with ivacaftor in subjects with CF, homozygous or heterozygous for the F508del-CFTR mutation who are in the Treatment Cohort.Part B and Part CNot…
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)
Primary Objective:To determine if the time in the desired glycemic range is equivalent by following the insulin infusion rate advice from the Glycostat algorithm compared to historical data in the ICU. The historical data for glycemic control…