17 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: efficacy of belimumab for the treatment of IMN.Secondary: safety and tolerability, PK, PD, quality of life, benefit of earlier treatment initiation.
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…
Primary: safety and tolerability of belimumab in a pediatric population (5-17 y) with SLE.Secondary: PK, efficacy, quality of life.
The primary objective is to assess whether combination treatment BLM+RTX will lead to reduced treatment failure and the improvement of pivotal, SLE-specific autoimmune phenomena compared SLE patients treated with standard of care.
To assess the influence of dosing guided by AutoK on achieving PK targets and clinical endpoints in intensive care patients with sepsis.
The primary objective is to characterize the PK profile of belimumab 200 mg SC in pediatric SLE participants.The secondary objectives are to evaluate the safety and tolerability of belimumab 200 mg SC in pediatric SLE participants and to…
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 evaluate the efficacy of belimumab in combination with standard of care in adult subjects with lupus nephritis Class III, IV, or V using the 2003 ISN/RPS criteria. * To assess the safety and tolerability of belimumab plus standard of care…
The primary goal of this study is to investigate the effects of belimumab on the composition of lymph nodes and the inflamed synovial tissue as well as (subsets of) immune cells in the peripheral blood. In addition, we will identify immunological…
Primary:To evaluate the efficacy of belimumab and a single cycle of rituximab administered in a combination regimen to adult participants with SLE. Secondary:Other aspects of efficacy. Safety and tolerability. Questionnaires.