7 results
• To evaluate the tolerability and safety of ascending single oral doses of ACT-541468 in healthy male subjects.• To investigate the single oral dose pharmacokinetic (PK) and PD of ACT-541468 in healthy male subjects.• To investigate dose…
The aim of this trial is to test in a first clinical study the above mentioned hypothesis that BAY63-2521 can at least partially correct deltaF508-CFTR function. Therefore, we plan to include patients with Cystic Fibrosis, who are homozygous for the…
The primary objective is to assess the proportion of patients in each treatment arm with a satisfactory clinical response as defined by a composite primary endpoint at Week 24.The secondary objective is to demonstrate safety and clinical effect at…
To evaluate the pharmacodynamic (PD) effects of the study treatments (ACT-541468 50 mg, ethanol at a blood level of 0.6 g/L for 5 h) as co-administration in 4 different combinations (ACT-541468 plus ethanol, ACT-541468 alone, ethanol alone, and…
The purpose of this study is to investigate the effectiveness and safety of riociguat (BAY 63-2521) in patients with diffuse cutaneous systemic sclerosis.
Therefore we aimed to study the 24 hour effect of twice daily aclidinium/formeterol versus once daily tiotropium on serial static and dynamic lung hyperinflation measurements, as well as (24 hour) symptoms and sleep quality. Tiotropium was chosen as…
Primary objective- To evaluate the effects of ACT-541468 on objective simulated driving performance, i.e., the standard deviation of the lateral position (SDLP), after single- and multiple dose administrations (i.e., on Day 1 and Day 4) in the…