104 results
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…
Primary Objective:The primary objective of this study is to evaluate the effect of SRP-4045 and SRP-4053 (combined-active group) compared to placebo onambulation, endurance, and muscle function at Week 96, as measured by the 6-minute walk test (6MWT…
- To evaluate the safety and tolerability of four oral dose levels of LTI-291 following multiple administrations in healthy middle-aged to elderly subjects. - To characterize the plasma and cerebrospinal fluid (CSF) pharmacokinetics (PK) of LTI-291…
Primary objective: Single-ascending dose (SAD) and multiple-ascending dose (MAD) phases of the study: *To establish the safety and tolerability of single- and multiple-ascending dose(s) of KHK6640, respectively, in subjects with prodromal Alzheimer*…
The purpose of the study is to investigate how quickly and to what extent BAY 1834845 is absorbed and eliminated from the body (this is called pharmacokinetics). In both study parts it will also be investigated to what extent BAY 1834845 is…
Objective(s)• To evaluate the safety and tolerability after intranasal administration of ascending multiple doses of Memogain in healthy elderly subjects.• To evaluate the PK after intranasal administration of ascending multiple doses of Memogain in…
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).
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 the effect of etrasimod on the values of specific ECG parameters. Importantly, the study will assess whether there is a prolongation of the QT interval following etrasimod treatment. When the QT interval is…
- To evaluate the safety and tolerability of four different single oral doses of LTI-291 in healthy subjects.- To characterize the plasma pharmacokinetics (PK) of LTI-291 following single oral dosing in healthy subjects.- To evaluate the…
The main objectives of this study are:To evaluate the safety and tolerability of three oral dose levels of LTI-291 following 28 days of LTI-291 treatment in patients with GBA-PDTo characterize the plasma and CSF pharmacokinetics (PK) of LTI-291…
* 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…
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 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: 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.…
To provide subjects who have completed participation in a Phase 2 or Phase 3 trial continued access to therapy and to evaluate the long-term safety and tolerability of leuco-methylthioninium bis(hydromethanesulfonate) given in flexible doses of up…
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…