102 results
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…
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…
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…
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…
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…
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…
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…
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…
* 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 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).
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.
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…
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…
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: 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 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…