9 results
The primary objective of the study is to evaluate the safety and tolerability of a range of single IV and SC doses of BG00010 in healthy volunteers, and a range of multiple SC doses of BG00010 in subjects with painful lumbar radiculopathy.Secondary…
The primary objective of the study is to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of 3 intravenous (IV) injections of BG00010 given on 2 fixed schedules; weekly and as frequently as every 48 hours (but no more than 3 times…
The primary aim of the phase I part of this trial is to establish the safety of a split dose regimen of Re-188-HEDP . The primary aim of the phase II part of this trial is to obtain insight in the efficacy of a split dose regimen of Re-188-HEDP , as…
Phase IThe primary aim of the phase I part of this study is to establish the safety profile and to determine the maximum tolerated dose of Re-188-HEDP combined with Capecitabine.Phase IIThe primary aim of the phase II part of this study is to obtain…
The primary aim of the phase I part of this study is to establish the safety profile and to determine the maximum tolerated dose of capecitabine combined with Re-188-HEDP.The primary aim of the phase II part of this study is to obtain insight in the…
Primary objectives:To establish a safe and effective dosing schedule for repeated administration of Rhenium-188 HEDP combined with Cabazitaxel in order to proceed with a Randomised Phase 2 trial designed to determine the clinical value of Rhenium-…
The objective of this trial is to compare standard treatment with radium-223-chloride (proven surivval benefit) with treatment with rhenium-188-HEDP, which is nowadays only used for pain palliation. This trial includes patients with metastatic…
The aim of this study is to investigate how quickly and to what extent aticaprant is absorbed, transported, and eliminated from the body (this is called pharmacokinetics). For this study, aticaprant is radioactively labelled with carbon-14 (14C). In…
To evaluate the relative oral bioavailability and dose proportionality of concept formulations compared with the reference formulation of aticaprant when administered in healthy adult participants. This part will be conducted by PRA.To evaluate the…