15 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…
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.
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…
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…
The purpose of the study is to find out if there is a possible influence of Ketoconazole on the effect of RO4602522 (this is called pharmacodynamics). it will be investigated whether and if so to what extent Ketoconazole influences how fast…
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 purpose of the study is to investigate how quickly and to what extent S 38844 and S 41015 are absorbed, distributed, metabolized (broken down) and eliminated from the body (this is called pharmacokinetics). Also the involvement of a specific…
To determine the maximum tolerated dose (MTD), dose limiting toxicities (DLT), and optimal dose of docetaxel that can safely be administered to patients with cancer in a weekly schedule. amendment 1The objective of the first amendment is to…
To determine whether polystyrene sulfonate has an effect on exposure of amitriptyline, when taken simultaneously, compared to amitriptyline taken alone in healthy volunteers, expressed in Cmax and AUC0-8h.
Primary: To evaluate the efficacy of ontamalimab as maintenance treatment of remission, based on composite score of patient reported symptoms and centrally read endoscopy, in subjects with moderate to severe ulcerative colitis (UC).Key Secondary:*…
Coprimary: The coprimary objectives of this study are to evaluate the efficacy of ontamalimab in subjects with moderate to severe Crohn*s disease (CD) in:* Inducing clinical remission based on 2 item patient reported outcome (PRO) (abdominal pain…
Primary: To evaluate the efficacy of ontamalimab in inducing remission, based on composite score of patient reported symptoms and centrally read endoscopy, in subjects with moderate to severe ulcerative colitis (UC).Key Secondary:* To evaluate the…
Coprimary: The coprimary objectives of the study are to evaluate the efficacy of ontamalimab as maintenance treatment in subjects with moderate to severe Crohn*s disease (CD) based on:* Clinical remission based on 2 item patient-reported outcome (…
To evaluate the safety and tolerability of long term treatment with ontamalimab in subjects with moderate to severe UC or CD.