A5103029925- Asthma and respiratory diseases
- Respiratory and Cough-Related Research
- Inhalation and Respiratory Drug Delivery
- Eosinophilic Esophagitis
- Eosinophilic Disorders and Syndromes
- Anesthesia and Pain Management
- Cardiomyopathy and Myosin Studies
- Migraine and Headache Studies
- Nausea and vomiting management
- Pharmaceutical studies and practices
- Heart Rate Variability and Autonomic Control
- Platelet Disorders and Treatments
- Diphtheria, Corynebacterium, and Tetanus
- Venous Thromboembolism Diagnosis and Management
- Neurological Disorders and Treatments
- Antiplatelet Therapy and Cardiovascular Diseases
- Maternal and Perinatal Health Interventions
- Pneumocystis jirovecii pneumonia detection and treatment
- Chronic Obstructive Pulmonary Disease (COPD) Research
- Thermoregulation and physiological responses
- Bone health and osteoporosis research
- Antifungal resistance and susceptibility
- Streptococcal Infections and Treatments
- Peroxisome Proliferator-Activated Receptors
- IL-33, ST2, and ILC Pathways
Teva Pharmaceuticals (United States)
2017-2020
University of North Carolina at Chapel Hill
2018
Hospital Garcia de Orta
2018
Merck & Co., Inc., Rahway, NJ, USA (United States)
2005-2015
Merck (United Kingdom)
2009
United States Military Academy
2004-2006
Merck (Japan)
2004
Liver X-receptor (LXR) agonists have been postulated to enhance reverse cholesterol transport (RCT), a process believed shuttle from the periphery back liver. Enhancing RCT via upregulation of transporters such as adenosine triphosphate-binding cassettes ABCA1 and ABCG1 could therefore inhibit progression atherosclerosis. LXR-623 is synthetic ligand for LXRs alpha beta that has shown promise in animal models The authors present results single ascending-dose study safety, pharmacokinetics,...
Aprepitant is the first NK1 receptor antagonist approved for use with corticosteroids and 5HT3 antagonists to prevent chemotherapy-induced nausea vomiting (CINV). The effective dose CINV a 125-mg capsule on day 1 followed by an 80-mg days 2 3. Study evaluated bioavailability of capsules estimated effect food. mean (95% confidence interval [CI]) bioavailabilities final market composition (FMC) capsules, as assessed simultaneous administration stable isotope-labeled intravenous (i.v.)...
ABSTRACT The potential for interactions between caspofungin and nelfinavir or rifampin was evaluated in two parallel-panel studies. In study A, healthy subjects received a 14-day course of alone (50 mg administered intravenously [IV] once daily) ( n = 10) with (1,250 orally twice 9) (600 10). B, 14 28-day daily), IV coadministered on the last days, 12 daily). coadministration/administration geometric mean ratio area under time-concentration profile calculated 24-h period following dosing...
WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • Calcitonin gene‐related peptide (CGRP) was first described as a potent vasodilator. CGRP is also increasingly recognized key player in the pathophysiology of migraine, and receptor antagonists potentially offer new approach for treating migraine. A novel pharmacodynamic assay to measure antagonist activity non‐invasively humans has been developed, which involves measuring increase dermal blood flow induced by topical application capsaicin on...
BACKGROUND: Ticagrelor is a reversible oral P2Y12 platelet inhibitor used to treat patients with acute coronary syndromes, prior myocardial infarction, high-risk artery disease, transient ischemic attack, or stroke. A healthy volunteer study showed that the intravenous monoclonal antibody bentracimab rapidly reverses ticagrelor, but effect in was unknown. METHODS: In prespecified interim analysis of single-arm, prospective study, evaluated ticagrelor-treated who required urgent surgery had...
BackgroundReslizumab displays efficacy in patients with inadequately controlled eosinophilic asthma; previous reports oral corticosteroid–dependent asthma are limited.ObjectiveTo assess of reslizumab and benefits on corticosteroid burden.MethodsWe report post hoc analyses pooled data from duplicate, placebo-controlled phase 3 trials. Patients aged 12 to 75 years controlled, moderate-to-severe were randomized 1:1 receive intravenous 3.0 mg/kg or placebo every 4 weeks for 52 weeks, stratified...
The aim of this study was to report the use intravenous calcium (Ca)-/zinc (Zn)-diethylene triamine penta-acetic acid (DTPA) for treatment 25 symptomatic patients diagnosed with gadolinium deposition disease (GDD).Written informed consent obtained. Twenty-five (18 women; mean age, 46.8 ± 15.3 years) a diagnosis GDD were included. All had received at least 1 administration (Gd)-based contrast agent. Patients 3 sessions Ca-/Zn-DTPA, 15 treatments spaced month apart, and 10 week apart. In all...
Telcagepant is a novel, orally active, and selective calcitonin gene-related peptide receptor antagonist being developed for acute treatment of migraine with without aura. Three separate clinical studies were conducted to evaluate the pharmacokinetics tolerability telcagepant following single oral doses in healthy young elderly men women multiple men. was rapidly absorbed time maximum concentration approximately 1.5 hours. The terminal half-life 6 A greater than dose-proportional increase...
A randomized, double-blind, placebo-controlled, 4-period crossover study was performed with a single oral dose of sitagliptin (100 mg, 800 mg), moxifloxacin (400 and placebo in order to provide rigorous assessment the effect on ventricular repolarization based ICH E14 guidance. The clinical 100 mg not associated an increase QTc interval, corrected using Fridericia correction (QTcf), at any time point. supratherapeutic 800-mg generally well tolerated minimal, clinically insignificant...
Abstract Background Arrhythmogenic cardiomyopathy (ACM) is a rare, progressive, autosomal dominant disorder characterized by increased risk of ventricular arrhythmias and sudden cardiac death. Up to 45% all ACM cases are caused pathogenic variants in the PKP2 gene, which encodes for desmosomal protein Plakophilin-2. This genetic referred as PKP2-ACM. AAVrh.74-PKP2a recombinant adeno-associated viral (AAV) vector containing coding sequence human isoform A (PKP2a) delivers functional gene...
The metabolic syndrome is characterized by an atherogenic dyslipidemia identifiable using lipoprotein subclass analysis. This study assesses the effect of a carbohydrate-restricted diet on in clinical setting.This retrospective chart review patients attending preventive medicine clinic analysis (by NMR spectroscopy) to identify dyslipidemia. If present, were counseled begin (< 20 g/day). Patients already statin therapy included only if medication dose was not changed. outcomes changes body...
Breath-actuated inhalers (BAI) eliminate the need for hand-breath coordination and, therefore, simplify delivery of inhaled medication.To evaluate efficacy and safety beclomethasone dipropionate BAI metered-dose inhaler (MDI) versus placebo in pediatric patients ages 4-11 years with persistent asthma.In this double-blind, double-dummy, phase III study, 628 children asthma were randomly assigned (1:1:1:1:1) to twice-daily (BAI 80 μg/day, 160 MDI or μg/day) placebo. Efficacy over 12 weeks was...
Breath-actuated inhalers (BAI) eliminate the need for hand-breath coordination required with standard metered-dose (MDI).To evaluate efficacy and safety of beclomethasone dipropionate (BDP) administered via BAI.This 6-week, phase III, double-blind study included patients aged ≥12 years persistent asthma. During single-blind run-in, discontinued asthma medications received twice-daily placebo BAI or MDI. At randomization, BDP 320 μg/day, 640 BAI, MDI μg/day Assessments standardized...
This study was designed to demonstrate that alendronate (ALN)/vitamin D3 combination tablets (ALN/D5600) are bioequivalent corresponding doses of ALN and vitamin as individual in healthy Taiwanese volunteers.In this open-label, randomized, 2-period, crossover study, 68 volunteers were randomized a single ALN/D5600 tablet or 70 mg + 5600 IU (2 × 2800 IU), followed by 12-day washout period administration the alternate formulation. Plasma levels measured using newly developed assay. Geometric...
A post hoc analysis of two randomized, placebo-controlled, Phase 3 trials intravenous reslizumab, an anti-interleukin-5 (IL-5) biologic for severe eosinophilic asthma.Relationships between baseline blood eosinophil levels (EOS), forced expiratory volume in 1 s (FEV1) reversibility to β2-agonists and treatment outcomes were assessed.Mean FEV1 was numerically lower among patients with high (≥ 400 cells/µL) versus low EOS. Reslizumab produced clinically significant improvement FEV1,...
<b>Background:</b> Intravenous (IV) reslizumab (RES), a humanized anti-interleukin-5 monoclonal antibody that reduced blood eosinophil (EOS) levels and clinical asthma exacerbations (CAE), improved lung function control, is approved for add-on therapy of adult patients with inadequately controlled severe eosinophilic asthma. <b>Aim/Objective:</b> To report RES immunogenicity as measured by anti-drug (ADA) response in all phase 3 studies, including placebo-controlled trials (PCT) long-term...
<b>Background:</b> Reslizumab (RES) significantly improves patient reported outcomes (PROs) including measures of asthma control, symptoms, and quality life (QoL) in adult patients (pts) with inadequately controlled eosinophilic (≥400 cells/µL). Blood eosinophil (EOS) levels are variable over time. <b>Aims/Objectives:</b> To assess changes PROs IV RES pts historically elevated blood EOS but <400 cells/µL at start therapy. <b>Methods:</b> Pts completed one two 52-week placebo...