5 results
Primary:To demonstrate the safety of enalapril Orodispersible Minitablets (ODMTs).Secondary:1. To describe the acceptability and palatability of enalapril ODMTs..2. To collect additional information about pharmacokinetics and pharmacodynamics of…
Primary:To obtain paediatric pharmacokinetic data of enalapril and its active metabolite enalaprilat in patients treated with enalapril ODMTs to describe the dose exposure in the paediatric population with CHD. Secondary:1. To demonstrate safety of…
Primary:To obtain paediatric pharmacokinetic data of enalapril and its active metabolite enalaprilat in paediatric patients treated with enalapril ODMTs to describe the dose exposure in the paediatric population with DCM.Secondary:1. To demonstrate…
The objective of this study is to evaluate [11C]MeDAS PET as a quantitative method for assessment of changes in myelin density over time and thus the efficacy of [11C]MeDAS PET to image myelin degradation and repair.
Part 1: dose optimizationTo identify a clinically active and tolerable systemic exposure range of bezuclastinib in subjects with AdvSMPart 2 Stage 1: Dose ConfirmationTo confirm the optimal dose of bezuclastinib in subjects with AdvSMPart 2 Stage 2…