View clinical trials related to Pharmacokinetics.
Filter by:This study is being conducted in order to assess the need for dose adjustment for elafibranor in patients with hepatic impairment. Pharmacokinetic parameters of elafibranor and its active metabolite (GFT1007) will be compared in hepatic impaired patients (mild, moderate and severe according to Child-Pugh categories) versus healthy participants after a single oral administration of elafibranor 120 mg.
Introduction: The prevalence of asthma and exercise-induced bronchoconstriction is high in the athletic population. In endurance sport, the prevalence has been reported to be as high as 30-50% compared to the general population prevalence of approximately 5-10% in Western countries. First-line treatment in asthma is reliever medication and inhaled corticosteroids (ICS). Therefore, β2-adrenoceptor agonists and ICS are commonly prescribed drugs to athletes. Although long-acting β2-agonists (LABA) are the most commonly used β2-agonists in asthma management, development of ultra-long acting β2-agonists (U-LABA) as vilanterol may change this. U-LABA has a long duration of action (24 hours) compared with LABA (12 hours). The accumulated number of inhalations per day for elite athletes may thus be reduced when prescribed with U-LABA as compared to LABA. Use of β2-agonists are restricted by the World Anti-Doping Agency (WADA). As of 2018, β2-agonists salbutamol, formoterol and salmeterol are allowed by inhalation in therapeutic doses, whereas other β2-agonists, such as terbutaline and vilanterol still require the athlete to obtain a therapeutic use exemption (TUE). To discriminate therapeutic use from supra-therapeutic misuse, WADA has established urinary thresholds and decision limits based on urine concentrations of salbutamol, salmeterol and formoterol. However, while data on urine concentrations of these three β2-agonists are well-described in studies that simulate sport-specific situations that are applicable for doping control, no such data exist for the novel U-LABA vilanterol. For instance, asthmatic athletes using β2-agonists usually inhale the drug before training or competition as prophylaxis for bronchoconstriction. Thus, studies are needed to investigate the urine concentrations of vilanterol after inhaled administration in set-ups that are applicable to doping control which this study aims to investigate. Method: The study is divided in two phases. The first phase consists of a pharmacokinetic pilot trial (EXP1). Depending on the analytical outcome of the pilot study, the study proceeds into the second phase, which is a larger pharmacokinetic trial (EXP2). Both EXP1 and EXP 2 are open label studies. EXP1: 6 healthy, well trained individuals are recruited to perform two trial days. First trial day consists of inhalation of the study drug in 4 times therapeutic dose followed by an exercise session. Before second trial day subjects inhales 4 times the therapeutic dose at home and on day 7 perform a training session. Urine and blood are collected in the following 72 hours both days. EXP2: 20 healthy, well trained individuals are recruited to perform four trial days in the same way as EXP1. But here both normal use and four times normal dose is investigated.
This is a single site, open-label, randomized, single-dose, Phase 1 study in post-menopausal women.
The purpose of this study is to assess pharmacokinetics of liposomal bupivacaine (Exparel) after multilevel intercostal injections of this local anesthetic for pain control during and after thoracoscopic surgeries. The specific aim of this study is to evaluate plasma concentration of bupivacaine after intraoperative intercostal injections of 266 mg of liposomal bupivacaine and compare it to plasma concentrations of bupivacaine after intercostal injections of 2mg/kg of 0.5% plain Bupivacaine with maximal dose of 30 ml or 150 mg. The hypothesis of the study is that plasma concentration of bupivacaine after intercostal injections of 266 mg of liposomal bupivacaine will be similar to concentrations after injections of plain bupivacaine, and will remain below the toxic level threshold range of 2000-3000 ng/mL (2-3 mg/L) at which central nervous system and cardiovascular adverse events would be expected to occur. The secondary objective is to evaluate if intercostal injections of 266 mg of liposomal bupivacaine will significantly reduce opioid consumption and postsurgical pain, within the first 48 hours and up to 3 months after minimally invasive thoracic surgeries, to determine if both acute and chronic post-thoracotomy pain can be decreased by intraoperative intercostal injections of liposomal bupivacaine. Additionally, the rate of pneumonia, the rate of atrial fibrillation and length of hospital stay will be assessed as secondary outcomes after thoracic surgeries. These outcomes can be affected by the level of postoperative pain and inflammation. Significance of this study: If positive, the results of this research have the potential to significantly improve pain management after thoracoscopic surgery. Based on prior experience, prolonged analgesia after liposomal bupivacaine injection is safe, and may help reduce perioperative opioid consumption and decrease opioid related complications. It will improve patient comfort, eliminate need for indwelling neuraxial catheters and risks associated with them.
This is a single-arm, open-label, Phase 4 study evaluating the effect of GO on the QTc, pharmacokinetics, safety, and immunogenicity of GO as a single-agent monotherapy in adult and pediatric patients with relapsed or refractory CD33-positive AML.
The current study will evaluate the plasma pharmacokinetics of amlodipine in a cohort of 8 adult volunteers who are receiving regular hemodialysis treatment (HD) 3 days a week for 4 hours each day and have been taking a total daily dose of 5-10 mg of amlodipine besylate for >30 days as part of their usual care. Blood sampling will occur over 13 hours, with frequent sampling during HD and in the 4 hours after termination of HD treatment. The 8 subjects will all receive their prescribed total daily dose of 5-10 mg 5 hours prior to HD treatment. The pre-HD sample will also be sent for pharmacogenomics genotyping. Safety and pharmacodynamic assessments (blood pressure (BP) and heart rate (HR) assessments) will be performed throughout the study. Axiom Precision Medicine Research Array (Affymetrix, Santa Clara, CA) will be used to evaluate genotype of CYP3A4. CYP3A4 phenotype will be evaluated using the ratio of parent drug to metabolite. Non-compartmental analyses will be performed to compare maximum concentrations (Cmax), time to maximum concentration and area under the curve from time 0 to the last measurable sample (AUClast) between the two phases. Compartmental analyses will be performed to construct a model to explain time-dependent changes in amlodipine clearance. Monte Carlo simulations will be performed to compare amlodipine pharmacokinetic profiles on and off HD.
The purpose of the study is to investigate the pharmacokinetics of oral dosage of Posaconazole which is routinely administered as a standard care prophylaxis for patients undergoing cancer treatments.
To evaluate the safety and pharmacokinetics of GV-971 capsules after oral a single or multiple doses of 900 mg, 1200 mg and 1500 mg in healthy subjects.
This is a multi-center, open-label, PK and safety study of VNRX-5133 and VNRX-5022 when co-administered in male and female subjects with varying levels of renal impairment and healthy normal controls.
The aim of this study is to elaborate nomograms to optimize amikacine first dosing in critically ill patients, using a population pharmacokinetics model elaborated with multicentric data.