78 results
The purpose of the study is to investigate how quickly and to what extent BIM23B065 is distributed, metabolized (broken down) and excreted from the body, and what the main route of excretion from the body is (urine or feces); this is called…
To investigate effect of tizanidine ER 12 mg on simulated driving performance, cognitive and psychomotor functions compared with placebo, tizanidine IR 8 mg (two 4 mg doses given 6.5 hours apart) and active-control in healthy subjects
Please refer to protocol, section 1.2 "Rationale"
A study to investigate the safety, pharmacokinetics and pharmacodynamics of a new recombinant human factor VIIa in healthy males, compared to Novoseven.
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…
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…
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…
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…
To assess the efficacy and safety of two Pasireotide LAR regimens in CD patients.
Study Stage 1:To evaluate the safety and tolerability of BaroFeron administered subcutaneously (SC)To determine the PK and PD profiles of BaroFeron administered SC and compare to Betaferon administered SCTo evaluate evidence of activity of BaroFeron…
To assess the efficacy of idebenone, compared to placebo, in improving or delaying the loss of respiratory function in patients with DMD
The primary objective of the PROTI study is to establish whether patients can correctly determine which treatment assignment they received during the randomised phase of the trial.The key secondary objective is to compare the rate of withdrawal from…
Primary objective: * Examine the safety and tolerability, both local and general, of ProCervix Solution (escalating doses) and ProCervix Powder in women infected by HPV 16 and/or 18 with normal cytology from Week 0 to Week 10. Secondary objectives…
Primary:To examine the effect of zolpidem on the pharmacokinetics (PK) of DS-5565 in human plasmaTo assess the safety and tolerability of concomitant administration of DS-5565 and zolpidem as defined by the adverse event (AE) profile.Secondary:To…
The primary objective of the study is to assess the safety and tolerability of BMS-708163 in patients with prodromal Alzheimer*s disease.
Primary Objective:- to evaluate the effect of treatment with omecamtiv mecarbil (OM) compared with placebo on the time to cardiovascular (CV) death of first HF event, whichever occurs first, in subjects with chronic HF with reduced ejection fraction…
The study will look at patients with relapsed (returned after prior treatment) and refractory (not responsive to prior treatment) multiple myeloma. The research aims to compare a new drug called elotuzamab combined with standard of care (…
In this study we will look at the blood levels of the study compound ziltivekimab. We will investigate how quickly and to what extent different compositions of ziltivekimab are absorbed, transported, and eliminated from the body. Ziltivekimab is not…
Primary objective: To assess the PK of oral FT011 in participants with diffuse SSc.Secondary objectives: • To assess the safety and tolerability of oral FT011 compared to placebo in participants with diffuse SSc.• To evaluate the short-term efficacy…
The purpose of this study is to evaluate, in patients with tumors known to express the protein mesothelin, the following properties of BAY2287411 injection: - safety (to identify, assess, minimize, and appropriately manage the risks associated to…