75 results
In this study we will investigate how safe the new compound seltorexant is and how well it is tolerated when it is used by healthy participants.We also investigate how quickly and to what extent seltorexant is absorbed, transported, and eliminated…
In this study we will investigate how safe specific doses of the compound paltusotine are and how well these are tolerated when they are used by healthy participants.We also investigate how much of the compound is broken down and absorbed in 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…
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…
To investigate the safety, tolerability and efficacy of STR-324 infusions in healthy subjects.Primary objective (Parts 1 and 2)* To assess and characterise the safety and the tolerability of STR-324, over a 4-hour (Part 1) and a 48-h infusion (Part…
The purpose of Part 1 is to investigate the effect of multiple doses of IMB-1018972 on the absorption, distribution and elimination of single doses of repaglinide and metformin and thereby understand to what extent IMB-1018972 may possibly change…
Primary* To evaluate safety and tolerability of LNP3794 at selected dose levelsSecondary* To determine the therapeutic relevant dose(s) of LNP3794* To describe the PK profile of LNP3794 following single and multiple oral administrationOther* To…
The purpose of this study is to find out how safe and effective the new drug PHA-022121 is for the treatment of Hereditary Angioedema. The main purpose of this research study is to test the effectiveness of 3 different doses of PHA-022121 in…
Primary Objective:- To evaluate the efficacy of efgartigimod compared to placebo in achieving a sustained platelet count response in patients with chronic primary immune thrombocytopenia (ITP), with a sustained platelet count response defined as…
Primary Objective• To estimate the long term safety of 100 mg and 200 mg once daily (QD) of abrocitinib with or without topical treatments in adult and adolescent subjects who previously participated in qualifying abrocitinib atopic dermatitis (AD)…
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…
The purpose of the study is to investigate to what extent GWP42003-P might lead to withdrawal effects after several weeks of dosing. Withdrawal effects are the signs and symptoms that can occur upon the abrupt discontinuation of some medications or…
Deulevodopa in combination with carbidopa is a combination in development for the treatment of patients with Parkinson*s disease.The effects of deulevodopa taken with carbidopa have not yet been tested in humans, and there are no available clinical…
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…
The purpose of the study is to investigate how quickly and to what extent somapacitan is absorbed, metabolized (broken down) and eliminated from the body (this is called pharmacokinetics). Somapacitan will be labeled with tritium (3H, a radioactive…
The purpose of the study is to investigate how quickly and to what extent cenerimod is absorbed, distributed, metabolized (broken down) and eliminated from the body (this is called pharmacokinetics).
During this study it will be investigated what the effect is of multiple doses of CBD on the absorption and elimination from the body (this is called pharmacokinetics) of clobazam, stiripentol or valproate. It will also be investigated what the…
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…
* To evaluate the safety and tolerability of adding multiple oral doses of HTL0018318 in elderly volunteers taking donepezil at steady state.* To compare the pharmacokinetic profiles of HTL0018318 and donepezil when given alone and in combination at…
Part A Pilot:The purpose of Part A is to investigate how quickly and to what extent exenatide is absorbed and eliminated from the body and whether the plasma levels of exenatide will reach the levels seen in patients with renal impairment. It will…