6 results
The primary objective of the entire study is to compare rogaratinib (BAY1163877) with chemotherapy (docetaxel, paclitaxel or vinflunine) in terms of prolonging the Overall survival (OS) of patients with FGFR positive urothelial carcinoma.
The purpose of this study is to investigate how quickly and to what extent rogaratinib is absorbed, distributed, metabolized (broken down) and eliminated from the body (this is called pharmacokinetics). Rogaratinib will be labelled with 14 Carbon (…
The hypothesis is that a switch from intravenous to oral antimicrobial therapy is non-inferior to standard intravenous therapy in patients with low-risk SAB. Therefore, the primary objective of the trial is to demonstrate, that oral switch therapy (…
The Primary Objectives for the study are:* Demonstrate the non-inferiority (NI) of lefamulin versus comparator with respect to the Early Clinical Response (96 ± 24 hours after the first dose of study drug) in the Intent to Treat (ITT) Analysis Set (…
Primary Objectives • To demonstrate if the impairment of cognitive function caused by mecamylamine administration can be diminished by an nAChR agonist or CEI.• To evaluate to what extent a single dose of 30 mg mecamylamine may cause a more…
The primary objective is to quantify the LIN AUC0-12h increase after addition of 250 mg, or 500 mg CLA compared to baseline (0 mg CLA). The secondary objectives are to describe the LIN and CLA pharmacokinetic parameters and to assess short-term…