75 results
The purpose of the study is to compare the hemodynamic effects (study of blood flow or circulation, such as blood pressure, heart rate, cardiac output (the volume of blood being pumped by the heart) and glomerular filtration rate (flow rate of…
Primary: to assess the bioequivalence of LH after administration of the freeze-dried (FD) Luveris formulation (Reference) versus the liquid formulation of Luveris in the pre-filled pen (Test) based on the PK parameters AUC0-t and Cmax of serum LH.…
Primary objective:To assess the safety, tolerability and pharmacokinetics of a single IV dosages of OTL-038. Selected doses of OTL-038 will be studied in the absence and presence of prophylactic treatment with the antihistamine clemastine to be…
To assess the safety of a single dose of intravenous EC17 injection in patients with ovarian, lung, breast cancer and parathyroid adenomas. To assess concordance of fluorescent signal and tumor status of resected tissue, in the case of ovarian, lung…
The primary objective of this study is to evaluate in subjects with LQT3:- The effect of oral eleclazine on mean daytime QTcF interval (in msec) after 24 weeks of treatment with eleclazine (based on standard 12-lead electrocardiogram [ECG] data)The…
Primary Objectives:* To investigate the pharmacokinetics of migalastat following a single 2hr IV infusion in healthy subjects.* To investigate the safety and tolerability of a single migalastat HCl 2hr IV infusion in healthy subjects.Secondary…
Primary Objectives1. To assess the safety and tolerability of ascending doses of a single IV injection of OTL-0382. To assess the efficacy of ascending doses of a single IV injection of OTL-038 in detecting ovarian, renal cell and endometrial cancer…
Primary objective:• To determine the efficacy of selinexor in adults with recurrent GBM asdetermined by the 6-months progression-free survival (6mPFS) rateSecondary objectives:• To determine the efficacy of selinexor in adults with recurrent GBM…
Primary objective: Safety and tolerability of repeated subcutaneous injections of MT203 in patients with mild to moderate RA.Secondary objectives: Pharmacokinetics, pharmacodynamics, including explorative biomarker assessments and efficacy of…
Primary ObjectivesTo quantify BCT197, and to identify and quantify its metabolites in plasma, urine, and feces.To determine the pharmacokinetics of total 14C-radioactivity in blood and plasma, and of any important metabolites in plasma and excreta.…
The purpose of the study is to evaluate the adhesiveness of two different patch formulations of rotigotine. This study is not intended to improve the health, but is necessary for the further development of the rotigotine patches
The main purpose of the study is to investigate whether the transdermal patch system HP-3070 shows blood concentrations of asenapine that make this route of administration suitable for clinical use. The transdermal route of administration is likely…
The primary objective of this study is to compare the overall survival (OS) of ramucirumab DP administered in combination with docetaxel versus docetaxel with placebo as therapy for patients with Stage IV non-small cell lung cancer (NSCLC) who have…
The primary objective of this study is to evaluate the hypothesis that cixutumumab given in combination with cisplatin and pemetrexed is superior to cisplatin and pemetrexed as first-line therapy for patients with advanced nonsquamous non-small cell…
The primary objective of this study is to evaluate the long-term safety and tolerability of LY2216684 administered once daily (QD) in the adjunctive treatment with a selective serotonin reuptake inhibitor (SSRI) for up to approximately 1 year in…
Primary : To assess the effect of multiple doses of rifampicin on the single-dose pharmacokinetics (PK) of tasquinimodSecondary : To assess the safety and tolerability of multiple doses of rifampicin with a single dose of tasquinimod
Primary:- To assess the effect of multiple doses of ketoconazole on the single-dose pharmacokinetics (PK) of tasquinimod.Secondary:- To assess the safety and tolerability of multiple doses of ketoconazole with single doses of tasquinimod.
The following research questions are formulated:A. Does exposure to cannabis (THC) result in an increased dopamine response in the striatum (as measured with PET)? And does cannabis use lead to an increase in psychotic experiences or symptoms?B. Do…
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…
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…