8 results
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…
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.
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-…
To study the influence of hepatic impairment on plasma pharmacokinetic parameters of eribulin mesylate (E7389) following an IV administration.
Dual Primary objective: - To demonstrate the superiority of Dato-DXd compared to ICC by assessment of PFS in participants with inoperable or metastatic HR-positive, HER2-negative breast cancer, who have been treated with 1 or 2 lines of chemotherapy…
Primary objective:To continue assessing the safety and tolerability of ANAVEX2-73.Safety and Tolerability Measures:* Physical examination* Vital signs (heart rate, respiratory rate, systolic blood pressure [SBP], diastolic blood pressure [DBP],…
The primary objective is to compare the pharmacological profile of the magistral form of dexamphetamine sulphate to the pharmacological profile of the brand-name form of dexamphetamine (Tentin©) in adult patients diagnosed with attention deficit…
Primary Objectives:* Change from baseline to week 48 in cognition according to the Alzheimer Disease Assessment Scale-Cognition (ADAS-Cog) compared to placebo.* Changes from baseline to week 48 in ability to perform daily activities according to the…