8 results
Primary objective• To assess the effect of cytochrome P450 3A4 enzyme (CYP3A4) induction by rifampicin on the pharmacokinetics (PK) of eribulin following intravenous (IV) administrationSecondary objectives• To assess the safety of eribulin when co-…
The primary objective of this study is to determine the excretion balance and to elucidate the metabolic pathway of eribulin in vivo after a single dose of carbon-14 radio-labeled eribulin (14C-eribulin), inpatients with advanced solid tumors.
The main objective is to determine if assisted hatching improves the live birth rate in poor prognosis patients. The secondary objective is to gather information on the safety of assisted hatching as determined by the number of congenital…
To study the influence of hepatic impairment on plasma pharmacokinetic parameters of eribulin mesylate (E7389) following an IV administration.
Primary objective: To study the influence of repeated oral administration of ketoconazole, a potent CYP3A4 inhibitor, in a therapeutic dose on the plasma pharmacokinetics (PK) of eribulin administered via intravenous (IV) infusion.Secondary…
To determine the effects of renal sympathetic denervation on insulin resistance and muscle sympathetic nerve activity (MSNA) in patients with metabolic syndrome at 3 months after renal denervation.
The purpose of this Clinical investigation is to further evaluate the safety and performance of the EnligHTN* Renal Denervation System in the treatment of patients with uncontrolled hypertension.
The aim of this post-CE study is to collect data on the effects of renal sympathetic denervation on the insulin resistance and muscle sympathetic nerve activity (MSNA) in patients with metabolic syndrome and associated hypertension.