22 results
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…
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…
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 study will be performed in 3 parts, Parts 1, 2 , 3. and 4 (DDI). The purpose of the study is to investigate how safe the compound is and how well the compound is tolerated; this will be investigated in all study parts. In Parts 1 and 2, it will…
In this study we will assess the effects of exenatide on cardiac metabolism and function in patients with T2DM and CHF. We will address the following hypothesis: exenatide improves global cardiac function in CHF patients with T2DM, by favorable…
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.
Overarching Aim: to detail the (mechanisms underlying the) actions of GLP-1RA and DPP-4i on the cardiovascular, renal and gastrointestinal system patients with T2DM. For the sake of clarity, we divide the study objectives into 3 parts:Primary…
The primary objective of EXSCEL will be to evaluate the effect of Bydueron, used in addition to the current usual care for glycemic control, on major macrovascular events when administered to patients with type 2 diabetes.
The primary objective is to determine whether additional treatment with exenatide in patients with acute myocardial infarction and treated with primary PCI, leads to a more preserved left ventricular function, compared to placebo in addition to…
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 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…
Overall objective:The overall objective is to test the hypothesis that GLP-1 receptor activation of CNS reward and satiety circuits occurs, in the context of food(-related) stimuli, and that this effect is altered in individuals with obesity and…
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…
Clinical trial to investigate a difference in effectiveness for the treatment of intertrigo in wich the combination of zinc oxide 10% in ketoconazole will to be compared with zinc oxide 10% and hydrocortisone-acetaat 1% in ketoconazole.
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 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…
The purpose of the study is to investigate to what extent Exenatide MPF is tolerated.It will also be investigated how quickly and to what extent Exenatide, when administered as Exenatide MPF, is absorbed and eliminated from the body (this is called…
Primary objective:To investigate the separate and combined actions of the SGLT2 inhibitor dapagliflozin and GLP-1 receptor agonist exenatide on activity in central reward and satiety circuits in response to food related stimuli in obese patients…
The main objective of the study is to determine the albuminuria lowering effect of the GLP1-RA exenetide, SGLT-2 inhibitor dapagliflozin and their combination in patients with type 2 diabetes and micro- or macroalbuminuria.Secondary objectives are…
The effect of Exenatide on brown adipose tissue activity and energy expenditure in healthy young men
Primary objective- To evaluate the effect of Exenatide treatment on brown adipose tissue activity and energy expenditure in healthy young Dutch male subjects of South Asian and white Caucasian descent. Secondary objective- To validate the MRI scan…