3 results
Approved WMOCompleted
Primary Objective: The primary objective of the study is to quantitatively determine the pharmacokinetics (absorption, distribution, metabolism, and excretion) of [14C]omacetaxine mepesuccinate and its metabolites in patients with relapsed and/or…
Approved WMOCompleted
Primary objectives of this study:1. Evaluate the efficacy after 26 weeks of Kuvan® treatment + Phe-restricted diet therapy in increasing dietary Phe tolerance, as compared to dietary therapy alone in <4 year-old infants and children with…
Approved WMOCompleted
Evaluate the long-term safety and effectiveness of two dose levels of orally administered BCX7353 in subjects with HAE