Search for a trial

Pharmacokinetics of fosfomycin: a study in patients with prolonged treatment for urinary tract infection

The aim of this study is to evaluate and describe the PK of fosfomycin in individuals receiving oral treatment with multiple dosages of fosfomycin for recurrent and/or complicatedurinary tract infection. The results of this study will be used to…

A study examining the pharmacodynamic interaction between buprenorphine and fentanyl

* To determine if buprenorphine action at the MOR receptor can inhibit the respiratory depression response to IV fentanyl injection in healthy subjects and patients with chronic opioid use;* To determine if therapeutic concentrations achieved with…

A Phase IIa Open Label Single Arm Study of Safety and Efficacy of rVA576 in Adult Mild to Moderate Bullous Pemphigoid Subjects

Primary Objective: To assess the safety of rVA576 in adult subjects with mild to moderate bullous pemphigoid (BP).Secondary Objectives: To assess the efficacy of rVA576 and its effect on the quality of life in adult subjects with mild to moderate…

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 1/2 open-label, multi-center, safety, preliminary efficacy and pharmacokinetic (PK) study of isatuximab (SAR650984) in combination with atezolizumab or isatuximab alone in patients with advanced malignancies

Phase1: To characterize the safety and tolerability of isatuximab in combination with atezolizumab in participants with unresectable hepatocellular carcinoma (HCC), platinum-refractory recurrent/metastatic squamous cell carcinoma of the head and…

Post-Market Clinical Investigation of the Clareon® IOL

Primary Objective:The primary objective of this study is to demonstrate the long-term (3 years) favorable visual acuity and adverse event outcomes for the Clareon IOL compared to historical SPE rates as reported in EN ISO 11979-7:2014.Secondary…

A 6-part first-in-human study of LOU064 consisting of a 4 part randomized, double-blind, placebo-controlled SAD and MAD study to investigate the safety and tolerability in healthy volunteers, subjects with atopic diathesis and subjects with atopic dermatitis, an open-label food effect study and a double-blind formulation effect study in healthy volunteers

To explore the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of LOU064 over a treatment period of 4 weeks in a cohort of subjects with atopic dermatitis.

HOT-REVA trial: Hyperbaric Oxygen Therapy for the treatment of RectoVaginal fistulas in Crohn*s disease.

To investigate the changes in fistula healing and quality of life after hyperbaric oxygen therapy in patients with Crohn's disease, and to assess the feasibility and safety of the treatment in these patients.

Clinical pharmacoloGy of platinUm-based hyperThermic intraperitoneal chemotherapy: exploration of the impact of flushing on tumOur, systemic and personnel eXposure

Primary objective:1. To explore the effect of flushing after HIPEC on tissue platinum exposureSecondary objectives:1. To explore the effect of flushing after HIPEC on wound exudate platinum concentration2. To explore the effect of flushing after…

Study to clinically evaluate the QT/QTc interval prolongation potential of vericiguat in patients with stable coronary artery disease in a 2-arm, placebo-controlled, randomized, double-blind, double-dummy design including a vericiguat multiple-dose part with fixed up-titration periods and moxifloxacin as positive control (for assay sensitivity testing, nested into the placebo treatment)

The objective of this study is to evaluate the effect of multiple doses of vericiguat on the QTcinterval in patients with stable CAD10 within the exposure range observed in Phase II/IIIstudies:Primary objective:* To investigate whether there is a…

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…

Interventional, open-label, single-group, multiple-dose study investigating the pharmacokinetic properties of arimoclomol (BRX-345) and its metabolites following oral administration to healthy young men

Primary objective: To investigate the pharmacokinetics (PK) of multiple doses arimoclomol in plasma en urine.To investigate and quantify metabolites of arimoclomol in plasma and urine (reported seperately)Secondary objective: To evaluate the safety…

Effect of the moderate CYP3A4-inhibitor erythromycin on the pharmacokinetics of palbociclib

The primary objective of this trial is to study the effect of the moderate CYP3A4 inhibitor erythromycin on the pharmacokinetics of palbociclib, measured as AUC0-24h, Cmax and Cmin.The secondary objective of this trial is to compare the incidence…

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.

Safety and Electrical Performance Evaluation of Invicta Leads Models Equipped with DF4 Connector.

Safety and electrical performance evaluation of Invicta leads moodels equipped with DF-4-connector.Clinical study to support the submission for acquiring the CE-mark.

US-guided Percutaneous needle tenotomy in Patients with Lateral Elbow Tendinopathy: A multicenter Randomized Controlled Trial

To study the effect of PNT and structured exercises on function and pain of patients with lateral elbow tendinopathy.

A Phase 2a Randomized, Double-Blind, Placebo and Active Comparator-Controlled, Parallel Group, Dose-Range Finding Study of MVT-602 in Healthy Premenopausal Women Undergoing Controlled Ovarian Stimulation (COS) Using a Minimal Stimulation Protocol.

To characterize the exposure-response relationship of MVT-602 effects on luteinizing hormone (LH) concentrations after subcutaneous administration of single 0.1 to 3 µg doses of MVT-602 or placebo in healthy premenopausal women undergoing COS to…

A multicenter, open-label, parallel-group study in study participants with epilepsy to evaluate the effect of oxcarbazepine on the pharmacokinetics, safety, and tolerability of padsevonil.

The primary objective of this study is to evaluate the effect of stable coadministered OXC (as monotherapy or adjunctive therapy) on the PK of PSL in study participants with epilepsy compared with study participants co-medicated with stable doses of…

Multiple dose escalation study in a multicenter, randomized, single-blind, parallel-group,
placebo-controlled design to investigate safety, tolerability, pharmacokinetics, and
pharmacodynamics of BAY 1213790 administered subcutaneously in healthy male subjects.

The purpose of this study is to investigate how safe the new compound BAY 1213790 is and how well it is tolerated when it is administered as an injection under the skin to healthy male volunteers. BAY 1213790 has been administered to humans before.…