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A Two-Part, Randomized, Placebo and Active-Controlled, Double-Blind, Thorough QT Study Evaluating the Effects of Intravenous Exenatide on Cardiac Repolarization in Healthy Male and Female Volunteers.

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…

A Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of LTI-291 in Healthy Middle-Aged to Elderly Subjects

- 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…

A Phase 1 Double-blind, Placebo-controlled, Single- and Multiple-ascending-dose Study of KHK6640 in Alzheimer's Disease

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*…

A Randomized, Placebo-Controlled, Double-Blind, Parallel Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of LTI-291 in Patients with Parkinson*s Disease and a GBA1 Mutation

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…

A randomized, double-blind, placebo and reference controlled, multiple ascending dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of Memogain administered by intranasal application to healthy elderly subjects.

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…

A randomized, double-blind, placebo and positive controlled, parallel group study to investigate the QTc exposure response, pharmacokinetics, safetyand tolerability after multiple therapeutic and supratherapeutic dosing of etrasimod (APD334) in healthy adult subjects

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…

A First-in-Human Randomized, Placebo-controlled, Double-blind, Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses of LTI-291 in Healthy Subjects

- 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…

A Phase 3 clinical study to determine the pharmacokinetics, safety and efficacy of rVWF:rFVIII and rVWF in the treatment of bleeding episodes in subjects diagnosed with von Willebrand disease

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…

A Randomized, Double-Blind, Phase 3 Study of Docetaxel and Ramucirumab versus Docetaxel and Placebo in the Treatment of Stage IV Non-Small Cell Lung Cancer Following Disease Progression after One Prior Platinum-Based Therapy

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…

A phase Ib double-blind, placebo-controlled, randomized, dose-escalating trial to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of repeated subcutaneous injections of MT203 in patients with mild to moderate rheumatoind arthritis (RA) on treatment with methotrexate.

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…

A Phase 1, Randomized, Double-Blind, Placebo Controlled, Single Dose Escalation Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of Migalastat Hydrochloride given Intravenously to Healthy Volunteers with an Open-Label, Randomized, Two-Way Crossover Arm

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…

A phase 1, placebo-controlled, single ascending-dose study to assess the safety, tolerability and pharmacokinetics of OTL-038 injection in healthy volunteers

Primary objective:To assess the safety, tolerability and pharmacokinetics of a single IV dosages of OTL-038. Selected doses of OTL-038 will be studied in the absence and presence of prophylactic treatment with the antihistamine clemastine to be…

Cardiovascular effects of apelin infusion in healthy male subjects

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…

A Phase 3, Single-Blind Study to Evaluate the Effect of Eleclazine on Shortening of the QT Interval, Safety, and Tolerability in Subjects with Long QT Syndrome type 3.

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…

A Double-Blind, Placebo-Controlled, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of SRP-4045 and SRP-4053 in Patients With Duchenne Muscular Dystrophy

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…

A randomised, double blind, parallel, placebo controlled, drug-drug interaction study to investigate the safety, tolerability and pharmacokinetics of multiple doses of HTL0018318 given alone and in combination with donepezil at steady state in elderly volunteers.

* 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…

A RANDOMIZED DOUBLE-BLIND TRIAL, USING A SINGLE-BLIND RUN-IN TO ASSESS WITHDRAWAL SYMPTOMS AFTER PROLONGED TREATMENT WITH CANNABIDIOL (GWP42003-P)

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…

A randomized, double-blind, placebo-controlled, multicenter Phase II study to determine efficacy and safety of IFX-1 in subjects with moderate to severe hidradenitis suppurativa

The primary objective of the study is to evaluate a dose-response signal of IFX-1 in subjects with HS according to the HiSCR at Week 16. The secondary objectives of the study are:* To assess the efficacy of IFX-1 using additional outcome measures*…

A Randomized, investigator/subject blind, adaptive, single and multiple ascending dose, placebo-controlled study to investigate safety, tolerability , pharmacokinetics, pharmacodynamics, food effect and taste of RO7017773 following oral administration in healthy participants.

Part 1, 2 and 3;To assess the safety and tolerability of single and multiple ascending doses of RO7017773 in healthy participants.To investigate the PK of RO7017773 in plasma and urine.To investigate the PD effects of RO7017773 treatment on specific…

A phase 1, randomized, double-blind, placebo-controlled study evaluating the pharmacokinetics of capsule and tablet formulations of VX-150, including the effects of food and milk, the relative bioavailability of the tablet formulation, and the drug-drug interaction between VX-150 and Midazolam, in healthy adults

The purpose of Part A of the study is to investigate to what extent VX-150 is tolerated when administered as a single dose (capsule). The effect of taking the dose with food and milk on how quickly and to what extent VX-150 is absorbed, distributed…