6 results
The primary objective of this study is to assess the renal safety of CSL112 in subjects with moderate RI and AMI after administration of up to 4 weekly infusions of CSL112.The secondary objectives of the study are:1. To further characterize the…
The objective of this study is to collect long-term safety and efficacy data for subjects treated with PCI-32765 and to provide ongoing access to PCI-32765 for subjects who are currently enrolled in PCI-32765 studies that have been completed…
To assess activated microglia in vivo in clinically and/or radiologically active RRMS patients compared to healthy controls using the PET-tracer [11C]SMW139, to assess retest variability in regional [11C]SMW139 brain uptake, and to evaluate which…
To assess the potential of the PET-tracer [11C]SMW139 to investigate the role of P2X7R, a cell surface receptor upregulated in activated microglia, in neuroinflammation in PD. The aim is to find the optimal tracer kinetic model which can be used to…
Run-in Part (Part 1)Objectives Primary* Confirm that the pharmacokinetics in pediatric subjects is consistent with that in adults Secondary* Evaluate the safety and tolerability of ibrutinib in combination with RICE or RVICI background therapy in…
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…