4 results
Primary Objectives• Safety and tolerability• PK of OCA and its conjugates o SD PK Phase: To assess the PK of OCA and its conjugates after a single low dose of OCA on Day 1 and determine subject eligibility for the MD Phase o MD Phase: To assess the…
To evaluate the long-term safety and tolerability of ralinepag (ADP811) in subjects who participated in a preceding Phase 2 or Phase 3 study of ralinepag.
The primary objective is to assess the effects of the combination of OCA and BZF on alkaline phosphatase(ALP) in comparison to BZF alone in subjects with primary biliary cholangitis (PBC)To assess the effects of the combination of OCA and BZF in…
To demonstrate the effect of ralinepag on the time to first adjudicated protocol-defined clinical worsening event in subjects with PAH.