31 results
Primary Objective• To compare the anti-tumor efficacy of oral single-agent rociletinib, as measured by investigator assessment of the progression-free survival (PFS), with that of single-agent cytotoxic chemotherapy in patients with EGFR mutated,…
Please refer to protocol, section 1.2 "Rationale"
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
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…
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…
PRM-151 is being developed for potential therapeutic use to prevent, treat and reduce fibrosis. This study will provide an assessment of the safety, tolerability, pharmacokinetics and pharmacodynamics of PRM-151 after administration of ascending…
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…
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 study is to assess the safety and tolerability of BMS-708163 in patients with prodromal Alzheimer*s disease.
A study to investigate the safety, pharmacokinetics and pharmacodynamics of a new recombinant human factor VIIa in healthy males, compared to Novoseven.
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…
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 objective of the first two cohorts of this study is to explore the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06372865 after a single dose across a wide exposure range up to the maximum tolerated dose or the maximum…
The primary objective of the study is to evaluate the safety and tolerability of a range of single IV and SC doses of BG00010 in healthy volunteers, and a range of multiple SC doses of BG00010 in subjects with painful lumbar radiculopathy.Secondary…
The purpose of this study is to test how well a new vaccine works to protect against shingles in people after they have received a transplant with their own blood stem cells.