102 results
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 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.…
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.…
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 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…
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…
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…
Primary objective:• Assess the pharmacokinetics (PK) of rVWF:rFVIII and rVWF, and to assess the safety and efficacy of rVWF:rFVIII and rVWF in the treatment of bleeding events in subjects with severe hereditary VWDSecundary objectives:• Compare the…
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 purpose of this study is to investigate how safe the new compound BMS-986224 is when it is administered as a single dose to healthy subjects and patients with chronic hart failure. It will also be investigated how quickly and to what extent BMS-…
Double-blinded part:The primary objectives of the study are as follows:• To investigate the safety and tolerability of 28 days of oral doses of SAR443060 in subjects with ALS.The secondary objectives of the study are as follows: • To characterize…
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 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…
The purpose of the study is to investigate how quickly and to what extent balovaptan is absorbed and eliminated from the body when it is administered to healthy volunteers. The pharmacokinetics of balovaptan given by mouth (oral) will be compared…
The purpose of this study is to investigate how quickly and to what extent the new compound BMS-986165 is absorbed and eliminated from the body (this is called pharmacokinetics) when it is administered to healthy volunteers without and with…
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 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…