5 results
To characterize the clearance pathways, the routes of excretion, total recovery of radioactivity, pacritinib and its major metabolites in healthy subjects following administration of a single oral dose of 400 mg [14C]pacritinibTo characterize the…
Primary:* To assess the effect of vedolizumab SC maintenance treatment on clinical remission at Week 52 in subjects with moderately to severely active UC who achieved clinical response at Week 6 following administration of vedolizumab IV at Weeks 0…
Primary objective:* To assess the effect of vedolizumab SC maintenance treatment on clinical remission at Week 52 in subjects with moderately to severely active CD who achieved clinical response at Week 6 following administration of vedolizumab IV…
Primary:* To obtain data on long term safety and tolerability on vedolizumab SC in subjects with Ulcerative Colitis (UC) or Crohn's Disease (CD).Secondary:* To obtain data on adverse events of special interest (AESIs; serious infections…
The primary objective of this study is to evaluate the performance of the Navigate Anti-AAV9 Antibody Assay using serum specimens in subjects with SMA in Novartis clinical studies COAV101B12301 *STEER* and COAV101B12302 *STRENGTH*.