8 results
The objective of the study is to improve medical treatment of Cushing's disease by combining partially independent medical therapies which act through differential mechanisms. Given the high affinity of SOM230 to sst5 and considering the facts…
Primary:To determine the effects of multiple-dose ketoconazole (Keto) on the pharmacokinetics of single-dose oral LBH589 in patients with advanced solid tumors.Secondary:In cancer patients with advanced solid tumors:* To assess the pharmacokinetic…
To evaluate the safety, tolerability, protein accretion, amino acid plasma levels and long-term outcome of Neoven compared to Vaminolact in preterm infants with a birth weight from 800 g to less than 1500 g and with a gestational age from 25 weeks…
Primary:- To assess the effect of multiple doses of ketoconazole on the single-dose pharmacokinetics (PK) of tasquinimod.Secondary:- To assess the safety and tolerability of multiple doses of ketoconazole with single doses of tasquinimod.
Primary objective:Compare the efficacy of BMS-936557 versus placebo for induction of clinical remission (defined as Mayo score * 2 points with no individual subscore > 1 point) at Week 7 (IP-50).Secondary objective* Compare the efficacy of…
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…
Primary:to evaluate the safety and tolerability of single dose administration of the study drug in healthy male subjectsto determine the pharmacokinetic parameters following single dose administration of the study drug in healthy male subjectso…
The primary endopoint is to determine whether ketoconazole/octreotide combination therapy, followed by octreotide monotherapy, is an effective treatment for Cushing's disease. Secundary endpoints address the effects of this therapy on bone…