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An open-label randomised cross-over study to evaluate the albuminuria lowering effect of dapagliflozin, exenatide and their combination in patients with type 2 diabetes

The main objective of the study is to determine the albuminuria lowering effect of the GLP1-RA exenetide, SGLT-2 inhibitor dapagliflozin and their combination in patients with type 2 diabetes and micro- or macroalbuminuria.Secondary objectives are…

A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Cross-over Phase 2 Study of Continuous 5-Hour Intravenous Infusions of BMS-986231 in Patients with Heart Failure and Impaired Systolic Function

Primary* Evaluate the effects of BMS-986231 on the left ventricular (LV) systolic function by stroke volume index (SVI) assessed by echocardiography compared to placebo. Secondary* Evaluate the effects of BMS-986231 on the left ventricular (LV)…

Optimal cerebral perfusion after an extracranial-intracranial bypass: should we increase blood pressure or cardiac output?

We aim to study what the mean change in graft flow rate is when the cardiac output is increased with 10% and what the mean change in graft flow rate is, when the blood pressure is increased with 10% to enable further research to establish whether an…

A Phase 1, Open-Label Study to Assess the Relative Bioavailability, Effect of Food, and Gastric pH Modification on the Pharmacokinetics of TAK-931 in Patients with Advanced Solid Tumors

Primary Objectives:Part 1- Estimate the relative bioavailability of the tablet formulation of TAK-931 in reference to the PIC formulation.Part 2- Assess the effect of a high-fat meal on the single dose PK of TAK-931 administered as the tablet…

A randomized cross-over trial in the effect of automated oxygen control devices on the distribution of oxygen saturation in preterm infants

To compare the effect of two automated oxygen controllers (Oxygenie and CLiO2) on time spent within oxygen target range in preterm infants.

Randomized, double blind, placebo- and active comparator- controlled 3-way crossover study in healthy subjects to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ENX-201

To assess PK of MPhs and MP.

Open label, partially randomized, cross-over study to determine the absolute bioavailability
and pharmacokinetics of BAY 1817080 using a simultaneous anticipated therapeutic oral
dose along with an i.v. [13C715N]-labeled microtracer and to investigate the relative
bioavailability of two formulations given under different diets at 2 dose levels in healthy
volunteers.

The main purpose of this study is to investigate how quickly and to what extent BAY 1817080 is absorbed (taken up), distributed, metabolized (broken down) and eliminated from the body (this is called pharmacokinetics). The pharmacokinetics of BAY…

A Multi-cohort, Randomized Study in Healthy Subjects to Assess the Pharmacokinetics and Safety of Single and Multiple Ascending Doses of JNJ-61393215 (Suspension), and to Assess the Relative Bioavailability, and the Effect of Food on the Pharmacokinetics, of a New Solid Formulation (Capsules) of JNJ-61393215

This study will be performed in 56 healthy volunteers. The study will be performed in 3 parts, Part 1, Part 2 and Part 3. Part 1 will be performed in 16 healthy volunteers divided over 2 groups of 8 volunteers each. The purpose of Part 1 of the…

Effect of the SGLT-2 inhibitor dapagliflozine on impaired awareness of hypoglycemia in type 1 diabetes

Primary objective: to investigate the effect of treatment with the SGLT-2 inhibitor dapagliflozin on the awareness of and counterregulatory hormone responses to hypoglycemia in people with type 1 diabetes and impaired awareness of hypoglycemia.…

An International, Multicenter, Open-label, Randomized, Phase 3 Study of BLU 285 vs Regorafenib in Patients with Locally Advanced Unresectable or Metastatic Gastrointestinal Stromal Tumor (GIST)

Primary Objective:* The primary objective is to demonstrate the efficacy of avapritinib based on progression-free survival (PFS) determined by central radiological assessment per modified Response Evaluation Criteria in Solid Tumors (mRECIST),…

A randomized, single-blinded, 3-way cross-over trial to investigate the pharmacokinetics of sustained release cysteamine bitartrate (PO-001) in healthy adult volunteers.

- To assess the pharmacokinetic profile of cysteamine base after single dose administration of the new sustained-release cysteamine bitartrate (PO-001) to healthy volunteers, in comparison with Cystagon® and Procysbi®.- To collect safety/…

A Multicenter, Randomized, Placebo-Controlled, Double-Blind Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAR443060 in Subjects with Amyotrophic Lateral Sclerosis (ALS)

Double-blinded part:The primary objectives of the study are as follows:• To investigate the safety and tolerability of 28 days of oral doses of SAR443060 in subjects with ALS.The secondary objectives of the study are as follows: • To characterize…

Morphine or Fentanyl for Refractory dyspnea in COPD

There are two main objectives for this study. First, we will investigate the following hypothesis: Fentanyl patches provide reduction of dyspnea compared to placebo, comparable to morphine, and with less side effects than morphine. Secondly, with…

Proton pump inhibition for secondary hemochromatosis in hereditary anemia, a phase III placebo controlled randomized cross-over clinical trial.

Primary Objective to show that PPIs compared to placebo are an effective treatment of secondary hemochromatosis in a relative large number of patients with hereditary anemia and mild iron overload. Secondary Objectives: To assess the safety and side…

A randomized, double-blind, double-dummy, placebo-controlled, three-way crossover study to investigate the effects of mexiletine and lacosamide on nerve excitability and evoked pain tests in healthy subjects.

Primary Objective- To evaluate the feasibility and test-retest variability of nerve excitability threshold tracking - To investigate the sensitivity of nerve excitability measures to detect the effects of mexiletine- To investigate the sensitivity…

The effect of lactate administration on cerebral blood flow during hypoglycemia

To investigate the effect of intravenous lactate administration, compared to placebo, on thalamic (regional) and global CBF during euglycemia and hypoglycemia in patients with T1DM and NAH.

Effect of High-volume Online hemodiafiLtration on intra-diaLytic hemodynAmic (iN)sTability and cardiac function in chronic hemodialysis patients (the HOLLANT study)

This study aims at improving the knowledge concerning HV-HDF and thus helps to tailor the optimal ERRT for each individual patient.The following hypotheses will be tested:1. Intra-dialytic hemodynamic stability is better preserved during HV-HDF as…

A Randomized, Double-blind, Placebo-Controlled, 3-Period Crossover Study Followed by 1 Open-label Comparator Period to Evaluate Central Pharmacodynamic Activity of TAK-653 in Healthy Volunteers Using Transcranial Magnetic Stimulation

The primary objective of the study is to determine whether TAK-653, in comparison to placebo, increases CNS excitability, assessed with TMS-evoked MEP in healthy subjects.Next to that, the study has the following goals: - To determine whether TAK-…

Biocomparison study of crushed elbasvir/grazoprevir compared to the whole tablet (CRUSADE-2)/Hep-NED005

Primary objective:To assess pharmacokinetic similarity of EBR/GZR as a crushed (test) Zepatier tablet compared to a whole (reference) tablet.Secondary objective:To assess Cmax similarity of EBR/GZR as a crushed (test) Zepatier tablet compared to a…

A single center, randomized study investigating the safety, tolerability, and pharmacokinetics of AZ-009 (Staccato apomorphine) in healthy volunteers and the safety, tolerability, pharmacokinetics, and pharmacodynamics of AZ-009 in subjects with established Parkinson*s Disease.

To examine the safety, tolerability, and pharmacokinetic profile of single ascending doses of AZ-009 compared to placebo (part B and C) or to Apo-Go (part A) in healthy volunteers being pretreated with domperidone and in patients with Parkinson…