6 results
Primary objective:To determine the pharmacokinetics of E7080 and its excretion balance in order to elucidate its metabolic profile in plasma, urine, and feces following a single oral dose of radiolabeled 14C-E7080 in patients with advanced tumors or…
The purpose of this research study is to compare 1 dose (15 ng/kg/minute) of Ularitide with a placebo-substance, to see whether Ularitide is safe and effective for the treatment of acute decompensated heart failure.
1. Assess the effectiveness of serial infusions of autologous selectively delipidated HDL/preβ enriched plasma following use of HDL Therapeutics PDS-2* System on lipid core burden in the study lipid core containing plaque segment(s) as assessed by…
Primary: • To evaluate the safety and effect on cholestasis of two seladelpar regimens (5 mg/day titrated to 10 mg/day and 10 mg/day) over 52 weeks of treatment compared to placeboKey Secondary: • To evaluate the effect of seladelpar on…
Primary Objective: • Efficacy: To evaluate the treatment effect of seladelpar on composite biochemical improvement in cholestasis markers based on alkalinephosphatase (ALP) and total bilirubin at 12 months of treatment compared to placebo• Safety:…
Primary:• To evaluate the long-term safety and tolerability of seladelparSecondary:• To evaluate the long-term efficacy of seladelpar• To evaluate the effect of seladelpar on patient-reported outcomes (pruritus)Exploratory• To evaluate the effect of…