123 results
The purpose of this study is to investigate how quickly and to what extent evobrutinib is absorbed, distributed, metabolized (broken down) and eliminated from the body (this is called pharmacokinetics). Part of the evobrutinib will be labelled with…
The primary objective of this study is to compare microglia activation as measured with proton Magnetic Resonance Spectroscopy (1H-MRS) between recent-onset schizophrenia patients who are randomised to CBD and those randomised to placebo. Secondary…
The primary objective for this study is as follows:* To evaluate clinical benefit in terms of PFS, as assessed by an IRF, for GA101 when used incombination with bendamustine compared with bendamustine alone in patients with indolentNHL refractory to…
The purpose of this study is to test the safety, tolerability and anti-tumor activity of the research study drug, Pembrolizumab (MK-3475) in combination with chemotherapy drugs of physician's choice (which includes Nab-paclitaxel, Paclitaxel or…
The primary objective is to compare, in healthy subjects, the injection site experience of a single dose of 0.25 mg semaglutide sc, given as the DV3396 product to that of the PDS290 product.
The objectives of this clinical trial are as follows:1. To assess the safety and tolerability of OLT1177 Capsule after oral administration in subjects with an acute gout flare2. To assess the clinical activity of various doses of OLT1177 Capsule in…
Primary objective1. To evaluate efficacy of ILT-101 for the preservation of residual pancreatic β cells function2. To select the optimal regimen of administration of ILT-101.Secondary objectivesTo assess:1. Tregs expansion after an induction period…
The objectives of this clinical trial are as follows:1. To assess the safety, tolerability, and pharmacokinetics of dapansutrile capsules after oral administration in subjects with chronic, well-controlled Schnitzler*s syndrome 2. To assess the…
The purpose of this study is to investigate how quickly and to what extent rogaratinib is absorbed, distributed, metabolized (broken down) and eliminated from the body (this is called pharmacokinetics). Rogaratinib will be labelled with 14 Carbon (…
The purpose of this study is to test the safety, tolerability and anti-tumor activity of the research study drug, Pembrolizumab (MK-3475) compared to other chemotherapy drugs of physician*s choice (which includes Capecitabine, Eribulin, Gemcitabine…
Primary:The primary objective of the study is to evaluate the efficacy of oral administration of dexpramipexole 150 mg twice daily compared to placebo for 12 months in subjects with ALS.Secondary:The secondary objectives of the study are to evaluate…
Core StudyPrimary objective• To compare the efficacy of E5501 (in addition to standard of care) to eltrombopag (in addition to standard of care) for the treatment of adult subjects with chronic immune thrombocytopenia (idiopathic thrombocytopenic…
The primary objectives of this study are to select an oral modified release (MR) formulation and dose of omecamtiv mecarbil for in subjects with HF and left ventricular systolic dysfunction and to characterize itspharmacokinetics (PK) after 20 weeks…
To assess the efficacy and safety of two Pasireotide LAR regimens in CD patients.
Primary Objective: To characterize the long-term safety and tolerability of AMG 416 in the treatment of SHPT in subjects with CKD on hemodialysisSecondary Objective: To characterize the long-term efficacy of AMG 416 on intact parathyroid hormone (…
Primary objective:To assess the BE under fasted conditions of BRV 10mg, 75mg, and 100mg oral tablets of commercial formulation vs BRV 50mg oral tablet(reference) of clinical development formulation,To assess the BA under fasted conditions of BRV…
PrimaryTo estimate the treatment effect of everolimus in combination with pasireotide LAR relative to everolimus alone on progression-free survival (PFS) in patients with advanced PNET and to assess the predictive probability of success in a…
To evaluate the efficacy of BRV at doses of 100 and 200mg/day compared to PBO as adjunctive treatment in adult focal epilepsy subjects with partial onset seizures not fully controlled despite current treatment with 1 or 2 concomitant AEDsTo assess…
The primary objectives for Part 1:-To determine the recommended Phase II dose of RO5424802 to be used in Part 2 of the study-To evaluate the safety and tolerability of 600mg and 900mg doses of RO5424802 administered twice daily to subjects with…
To investigate the effect of modafinil (200 mg) and caffeine (300 mg) on vigilance in low, medium and high caffeine consumers during the circadian trough in order to determine the best pharmacological agent to target fatigue.