3 results
Approved WMOCompleted
Primary: to assess the bioequivalence of LH after administration of the freeze-dried (FD) Luveris formulation (Reference) versus the liquid formulation of Luveris in the pre-filled pen (Test) based on the PK parameters AUC0-t and Cmax of serum LH.…
Approved WMOPending
Primary:• Progression-free survival (PFS) of unesbulin plus dacarbazine (DTIC) versus placebo plus DTICSecondary:Efficacy:• Overall survival (OS) of subjects treated with unesbulin plus DTIC versus placebo plus DTIC• Antitumor activity of unesbulin…
Approved WMOCompleted
The objective of the study is to evaluate safety, tolerability, and pharmacokinetics (PK) of ALKS 6610 after single ascending oral doses in healthy adult subjects.