58 results
The objective of this study is to determine the safety and effectiveness of the Surpass NeuroEndoGraft* System in the endovascular treatment of large or giant wide-necked intracranial aneurysms (IA) in internal carotid artery up to the terminus.
Primary Objective: - to evaluate the pharmacokinetic (PK) parameters (AUC0-t, AUC0-inf, Cmax, C24hr, Tmax, and apparent t*) of MK-3682 and its circulating metabolites (IDX20664 and IDX23267), MK-5172, and MK-8742 following administration of two…
- to evaluate the pharmacokinetic (PK) parameters (AUC0-t, AUC0-*, Cmax, C24, Tmax, and apparent t1/2) of MK-3682 and its circulating metabolites (IDX20664 and IDX23267), MK-5172, and MK-8408 following administration of the fixeddose combination…
The purpose of the study is to investigate how quickly and to what extent JZP-507 is absorbed and eliminated from the body (this is called pharmacokinetics). This will be compared to the pharmacokinetics of Xyrem®. If the results show that the…
The primary objective of this study is to assess the efficacy of gabapentin as add-on to morphine for the treatment of severe chronic neuropathic or mixed pain in children from 3 months to less than 18 years of age. Secondary objectives 1. To assess…
Primary Objective- To determine safety and tolerability of a single dose of ZW800-1 in healthy volunteers.Secondary Objectives- To determine the pharmacokinetics of a single dose of ZW800-1 by measuring the fluorescence of blood and urine.- To…
Primary objective: To investigate the pharmacokinetics (PK) of multiple doses arimoclomol in plasma en urine.To investigate and quantify metabolites of arimoclomol in plasma and urine (reported seperately)Secondary objective: To evaluate the safety…
* To evaluate the safety and tolerability of CyPep-1 when applied on healthy skin for up to one week. * To evaluate the safety and tolerability of CyPep-1 when applied to cutaneous warts for up to four weeks.* To evaluate the activity of the CyPep-1…
The objectives of this exploratory study are: * To evaluate the safety and local tolerability of the new flurbiprofen 8.75 mg spray. * To compare the pharmacokinetic profile of the new flurbiprofen 8.75 mg spray to marketed flurbiprofen 8.75 mg…
HV cohort 1Primary Objectives* To characterize the local tolerability of topical bimiralisib after 21 days* To characterize the systemic PK of topical bimiralisib after 21 daysSecondary Objective* To characterize the safety of topical bimiralisib…
1. A better understanding of the apraglutide dose/concentration-effect relationship;2. A better understanding of duration of effect (apraglutide kinetics in relation to citrulline kinetics).
Part 1Primary ObjectiveTo evaluate the local and systemic safety and tolerability of INM-755 cream following repeated once-daily topical applications for 14 days on healthy skin of healthy volunteersSecondary ObjectiveTo assess the local and…
Primary Objective:* To evaluate the effect of EDP-305 on alkaline phosphatase (ALP) levels.Secondary Objective:* To evaluate the safety and tolerability of EDP-305* To evaluate the effect of EDP-305 on bilirubin levels* To evaluate the effects of…
Primary ObjectivesTo assess the efficacy of 0.13mg/kg EMI-137 IV injection to detect lesions during colonoscopy, in subjects at high suspicion of developing colorectal cancer by:- Comparing the number of pathological lesions detected with WL with…
The purpose of this study is to investigate how safe the new compound JHL1922 is when it is administered to healthy subjects. JHL1922 has not been administered to humans before, but it has been previously tested in the laboratory. In this study, the…
Primary* To evaluate the effect of EDP1066 in multiple formulations on the systemic immune system.Secondary* To evaluate the safety and tolerability of EDP1066 in multiple formulations.
Primary* To evaluate the effect of IW-6463 on cerebral blood flow (CBF) in healthy elderly participants* To assess the safety and tolerability of IW-6463 vs placebo when administered to healthy elderly participants for up to 15 daysExploratory* To…
The purpose of this study is to investigate how quickly and to what extent derazantinib is absorbed (taken up), distributed, metabolized (broken down) and eliminated from the body. The pharmacokinetics of derazantinib when it is administered…
Primary Objective: To characterize the effect of repeat-dose administration of brigatinib 180 mg QD on the single-dose PK of midazolam.Other Objectives:Safety: To assess the safety and tolerability of brigatinib in patients with ALK-positive or ROS1…
Primary objective:- To evaluate safety and tolerability of LRX712 after a single i.a. injection in OA patients.Secondary objective: - To evaluate LRX712 and metabolite MAE344 pharmacokinetics in plasma.Exploratory objectives:- To evaluate LRX712 and…