102 results
The primary objective of the study is To evaluate the efficacy of BG00011 compared with placebo in subjects with IPF.The secondary objectives of the study are:* To evaluate the efficacy of BG00011 compared with placebo in subjects with IPF as…
To evaluate the safety, including tolerability, of ISIS 681257 and to assess the efficacy of different doses and dosing regimens of ISIS 681257 for reduction of plasma Lp(a) levels in patients with hyperlipoproteinemia(a) and established CVD.To…
Therefore, in the DUET-trial we will investigate whether double J stenting is indeed superior to the use of an external stent in reducing the number of urological complications after kidney transplantation, as measured by the number of PCN…
The purpose of this study is to investigate how safe the new compound BMS-986278 is when it is administered as a single dose to healthy subjects. BMS-986278 has not been administered to humans before. It has been previously tested in the laboratory…
The purpose of this study is to investigate the safety and tolerability of different doses of neosaxitoxin when it is administered to healthy male volunteers alone and in combination with bupivacaine (with and without epinephrine) in perineural…
The purpose of the study is to investigate the effect of inarigivir on the absorption, distribution and elimination of midazolam in order to assess to what extent inarigivir may possibly change the pharmacokinetics of other drugs when given with…
The purpose of the study is to investigate how quickly and to what extent 2 different production batches of alpelisib (FMI and FMIopt) are absorbed and eliminated from the body (this is called pharmacokinetics). In this study it is investigated…
The purpose of this study is to explore if the (f)MRI- and behavioral assessment are reproducible and suitable for drug studies performed at more than one medical center or clinic.
Part 1, 2 and 3;To assess the safety and tolerability of single and multiple ascending doses of RO7017773 in healthy participants.To investigate the PK of RO7017773 in plasma and urine.To investigate the PD effects of RO7017773 treatment on specific…
OBJECTIVES of the Study:Primary ObjectiveTo evaluate if the addition of ibrutinib to R-CHOP prolongs event-free survival (EFS) compared withR-CHOP alone in subjects with newly diagnosed non-GCB DLBCL.Secondary ObjectivesTo compare ibrutinib in…
1. To assess safety of different doses of a single iv injection of SGM-1012. To assess the performance of SGM-101 in the intraoperative detection of colorectal or pancreas cancer by:a. Tumor-to-background ratio (TBR);b. Concordance between…
The study will be performed in 2 parts, Part 1 and Part 2). The purpose of the study is to investigate how quickly and to what extent Olesoxime is absorbed and eliminated from the body. In addition, it will be investigated how safe Olesoxime is and…
The purpose of Part A of the study is to investigate to what extent VX-150 is tolerated when administered as a single dose (capsule). The effect of taking the dose with food and milk on how quickly and to what extent VX-150 is absorbed, distributed…
The primary objective of the study is to evaluate a dose-response signal of IFX-1 in subjects with HS according to the HiSCR at Week 16. The secondary objectives of the study are:* To assess the efficacy of IFX-1 using additional outcome measures*…
To assess the safety and tolerability and to define the dose limiting toxicities (DLT) and maximum tolerated dose (MTD) of BMS-986158 as for subjects with selected advanced solid tumors.
The purpose of the study is to investigate the effect of etrasimod on the values of specific ECG parameters. Importantly, the study will assess whether there is a prolongation of the QT interval following etrasimod treatment. When the QT interval is…
To investigate the safety, tolerability and efficacy of STR-324 infusions in healthy subjects.Primary objective (Parts 1 and 2)* To assess and characterise the safety and the tolerability of STR-324, over a 4-hour (Part 1) and a 48-h infusion (Part…
The purpose of this study is to investigate how quickly and to what extent the new compound BMS-986165 is absorbed and eliminated from the body (this is called pharmacokinetics) when it is administered to healthy volunteers without and with…
The primary objective of this phase 2 study in patients with advanced endometrial cancer is to compare the clinical efficacy of MLN0128 + weekly paclitaxel to weekly paclitaxel alone in second- or third-line treatment of advanced, recurrent, or…
The sponsor is developing a compound (PB006) similar to Tysabri® (natalizumab, hereafter referred to as Tysabri). As part of medical-scientific studies to confirm the similarity of the two compounds, the Sponsor wants to compare PB006 with EU-…