5 results
For Part A: the purpose of this part is to investigate the effect of multiple oral doses of the new study drug on how quickly and to what extent glimepiride is absorbed and eliminated from the body (this is called pharmacokinetics), if glimepiride…
Primary Objective:• To evaluate the safety and tolerability of danavorexton single IV infusion administered in healthy subjects undergoing OIRD.Secondary Objective:• To assess the PK of danavorexton single IV infusion administered in healthy…
The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics and activity of ACP-196 in treating subjects with Waldenström disease.
The purpose of this study is to evaluate the efficacy, activity, safety, pharmacodynamics and pharmacokinetics of ACP-196 in treating subjects with Mantle Cell Lymphoma (MCL)
Therapy:The investigational product, ACP-196, will be supplied as hardgelatin capsules for oral administration.Commercially available ibrutinib (IMBRUVICA®) will be used asthe reference therapy.Objectives: Primary Objective:To assess whether ACP-196…