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…
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…
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…
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 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…
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*…
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 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-…
The purpose of this study is to evaluate the effectiveness of the BMS-986259 study drug on blood pressure events in stable participants diagnosed with heart failure admitted to the hospital with Acute Decompensated Heart Failure (ADHF).
The purpose of this study is to investigate how quickly and to what extent HDM201 is absorbed, broken down and eliminated from the body (this is called pharmacokinetics). HDM201 will be labeled with 14-carbon (14C) and is thus radioactive. In this…
The purpose of this study is to investigate how safe modafinil is and how well it is tolerated when it is administered in combination with aniracetam to generally healthy elderly volunteers with subjective cognitive decline. Modafinil and aniracetam…
The purpose of Part 1 is to investigate the effect of multiple doses of IMB-1018972 on the absorption, distribution and elimination of single doses of repaglinide and metformin and thereby understand to what extent IMB-1018972 may possibly change…
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 safe the new compound BMS-986337 is and how well it is tolerated when it is administered as single or multiple doses to healthy volunteers. BMS-986337 has not been administered to humans before. It has…
Primary- Phase 1: To determine the recommended dose (RD) of cabiralizumab in patients with pigmented villonodular synovitis (PVNS)/diffuse type tenosynovial giant cell tumor (dt-TGCT)- Phase 2: To estimate the objective response rate (ORR = CR+PR)…
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…
Primary objective:To demonstrate the efficacy of Rifaximin -EIR 400 mg Tablet (800mg /BID, total daily dose 1600 mg) versus placebo in the prevention of endoscopic Crohn*s disease recurrence following ileocolonic resection