- Helicobacter pylori-related gastroenterology studies
- Gastroesophageal reflux and treatments
- Innovations in Medical Education
- Antibiotics Pharmacokinetics and Efficacy
- Pharmacological Effects and Toxicity Studies
- Pharmacogenetics and Drug Metabolism
- Analytical Methods in Pharmaceuticals
- Clinical Reasoning and Diagnostic Skills
- Pharmacology and Obesity Treatment
- Health Systems, Economic Evaluations, Quality of Life
- Vitamin D Research Studies
- Cardiac electrophysiology and arrhythmias
- Computational Drug Discovery Methods
- Ion Transport and Channel Regulation
- Simulation-Based Education in Healthcare
- Biomedical Ethics and Regulation
- Pharmaceutical studies and practices
- Ethics in Clinical Research
- Receptor Mechanisms and Signaling
- Gastrointestinal motility and disorders
- Cardiovascular Function and Risk Factors
- Antibiotic Use and Resistance
- Radiology practices and education
- Atrial Fibrillation Management and Outcomes
- Asthma and respiratory diseases
Ark Medical Center
2020-2021
Kaweah Delta Health Care District
2017-2021
Hamilton Medical Center
2021
College of Charleston
2021
University of South Carolina
2021
Memorial Health University Medical Center
2021
Stanford University
2021
Mount Sinai Beth Israel
2020
Icahn School of Medicine at Mount Sinai
2020
St. Joseph’s University Medical Center
2020
Transthyretin amyloidosis is caused by the deposition of hepatocyte-derived transthyretin amyloid in peripheral nerves and heart. A therapeutic approach mediated RNA interference (RNAi) could reduce production transthyretin.
Summary Background TAK ‐438 (vonoprazan) is a potassium‐competitive acid blocker that reversibly inhibits gastric H + , K ‐ ATP ase. Aim To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of in healthy Japanese non‐Japanese men. Methods In two Phase I, randomised, double‐blind, placebo‐controlled studies, men (Japan N = 60; UK 48) received 10–40 mg once daily at fixed dose level for 7 consecutive days. Assessments included (intragastric pH ). Results Plasma...
Deferasirox (ICL670) is a novel once-daily, orally administered iron chelator to treat chronic overload in patients with transfusion-dependent anemias. Absorption, distribution, metabolism, and excretion of [<sup>14</sup>C]deferasirox at pharmacokinetic steady state was investigated five adult β-thalassemic patients. (1000 mg) given once daily for 6 days achieve state. On day 7, received single oral 1000-mg dose (∼20 mg/kg) (2.5 MBq). Blood, plasma, feces, urine samples collected over 7 were...
Background and Purpose Anaemia of chronic disease is characterized by impaired erythropoiesis due to functional iron deficiency, often caused excessive hepcidin. Lexaptepid pegol, a pegylated structured l ‐oligoribonucleotide, binds inactivates Experimental Approach We conducted placebo‐controlled study on the safety, pharmacokinetics pharmacodynamics lexaptepid after single repeated i.v. s.c. administration 64 healthy subjects at doses from 0.3 4.8 mg·kg −1 . Key Results After treatment...
To assess the steady-state pharmacokinetic and QT(c) effects of domperidone ketoconazole, given alone together.A randomized, placebo-controlled, double-blind, crossover study was carried out. Healthy subjects (14 men, 10 women; age 18-39 years; mean weight 73.5kg, range 53.8-98.8kg; 23 Europid, 1 Afro-Caribbean) received orally, for 7 days each, placebo, 10mg, four doses daily, at 4h intervals, ketoconazole 200mg 12-hourly together. The washout period 15 days. Pharmacokinetics serial 12-lead...
The aim of the present study was to investigate whether selective antagonism cysteine-X-cysteine chemokine receptor-2 (CXCR2) receptor has any adverse effects on key innate effector functions human neutrophils for defence against microbial pathogens.In a double-blind, crossover study, 30 healthy volunteers were randomized treatment with CXCR2 antagonist AZD5069 (100 mg) or placebo, twice daily orally 6 days. peripheral blood neutrophil count assessed at baseline, during and in response...
FP-01.1 is a novel synthetic influenza A vaccine consisting of six fluorocarbon-modified 35-mer peptides that encapsulate multiple CD4+ and CD8+ T-cell epitopes designed to induce an immune response across broad population.FP-01.1 was evaluated for safety immunogenicity in randomised, double-blind, placebo-controlled, dose-escalation, phase I clinical study healthy adult volunteers (n=49). IFNγ ELISpot assays multicolour flow cytometry were used characterise the response.FP-01.1 safe well...
Aims To compare the pharmacokinetics, safety, tolerability and immunogenicity of FKB327, a biosimilar adalimumab, with European Union (EU)‐approved Humira US‐licensed after single subcutaneous doses in healthy subjects. Methods In randomized, double‐blind, parallel‐group study, 180 subjects received by injection 40 mg EU‐Humira, or US‐Humira, 1:1:1 ratio, stratified bodyweight. Pharmacokinetics, local tolerability, immunogenicity, adverse events, vital signs, electrocardiography laboratory...
Relebactam is a novel class A and C β-lactamase inhibitor that being developed in combination with imipenem-cilastatin for the treatment of serious infections Gram-negative bacteria. Here we report on two phase 1 randomized, double-blind, placebo-controlled pharmacokinetics, safety, tolerability studies relebactam administered or without to healthy participants: (i) single-dose (25 1,150 mg) multiple-dose (50 625 mg every 6 h [q6h] 7 14 days) escalation study men (ii) (125 women elderly...
The pharmacokinetics of Gd-DOTA meglumine in humans were evaluated six healthy male volunteers. agent was injected intravenously at 0.1 mmol/kg over approximately 2 minutes. Its behavior found to be similar that urographic and angiographic iodinated contrast media with a plasma elimination half-life 91 ± 14 minutes (mean standard deviation [SD]), small distribution volume 171.0 19.7 mL/kg rapid urinary excretion. results suggest passive extravascular diffusion gadolinium (Gd)-DOTA the...
The inhibition of fatty acid amide hydrolase 1 (FAAH) has been proposed as a novel mechanism for treating pain syndromes by increasing the levels endogenous cannabinoids (ECs). This study describes safety, tolerability, pharmacokinetics and pharmacodynamics V158866, reversible FAAH inhibitor, after first administration to man. 51 healthy male subjects were recruited into this double-blind, randomised, placebo-controlled, adaptive dose, phase I single (Part A) repeated ascending dose B)...
A cross‐over study of glycosylated and non‐glycosylated G‐CSF was performed in 20 healthy male volunteers to compare the effects different forms G‐CSF, extent inter‐individual progenitor cell mobilization determine whether any differences observed were related serum concentrations attained. The peak WBC achieved during 6 d administration at a dose 5 μg/kg/d significantly higher with than product ( P = 0.02) as level granulocyte‐monocyte colony forming cells (GM‐CFC) 0.03). average GM‐CFC...
Summary Aim : To compare the antisecretory effects of rabeprazole and esomeprazole in an open, randomized, two‐way crossover, clinical pharmacology study. Methods Twenty‐four healthy subjects (14 men, 10 women; mean age 26.8 years) received 20 mg or daily on days 1–5, witha 14‐day ‘wash‐out’. Intragastric pHwasrecordedcontinuously, serum gastrin measured, 0, 1 5. Results On day intragastric pH AUC was significantly higher before than treatment four five time intervals analysed. 5, after...
To assess safety, tolerability, pharmacokinetics and hemodynamic effects of oral CF 101, an A3 adenosine receptor (A3AR) agonist, in healthy men.One single 1 repeated dose, parallel-group, ascending double-blind placebo-controlled study normal volunteers. In the dose study, n = 15 subjects received 1, 5 or 10 mg CF101; each group subject placebo, remainder active CF101. repeat-dose 28 12-hourly doses 101 (2, 3, 4 mg) for 7 days, 2 TEST MATERIALS: Single-dose study: CF101 30% Cremophor RH40....
Aims Two randomized, double‐blind, placebo‐controlled studies were performed to characterize the safety, tolerability, pharmacokinetics ( PK ) and pharmacodynamics PD of investigational metastin analogue, TAK ‐683, in healthy men. Methods We first investigated a single subcutaneous s.c. dose ‐683 (0.01–2.0 mg) 60 subjects n = 42; placebo, 18). then assessed bolus 0.03–1.0 mg on day 1, followed by 0.01–2.0 −1 continuous infusion days 2–13, simulate depot formulation, 30 25; 5) for 14 days....
Two double-blind, randomized studies were conducted to assess the tolerability, pharmacokinetics and pharmacodynamics of oral TA-8995, a new cholesteryl ester transfer protein (CETP) inhibitor, in healthy subjects.Study 1: Subjects received single doses TA-8995 or placebo (fasted). Doses 5, 10, 25, 50 (fed/fasted), 100 150 mg (Caucasian males, 18-55 years), 25 > 65 years Caucasian females, 50, (Japanese years). Study 2: males (18-55 years) 1, 2.5, 10 once daily for 21-28 days. Blood urine...
The current standard of care for treating Alzheimer's disease is acetylcholinesterase inhibitors, which nonselectively increase cholinergic signaling by indirectly enhancing activity nicotinic and muscarinic receptors. These drugs improve cognitive function in patients, but also produce unwanted side effects that limit their efficacy. In an effort to selectively cognition avoid the associated with care, various efforts have been aimed at developing selective M<sub>1</sub> receptor...
Taranabant is a novel cannabinoid CB‐1 receptor (CB1R) inverse agonist in clinical development for the treatment of obesity. This double‐blind, randomized, placebo‐controlled, single oral dose study evaluated safety, tolerability, pharmacokinetics, and pharmacodynamics taranabant (0.5–600 mg) 24 healthy male volunteers. Single‐dose AUC 0‐∞ C max values increased approximately linearly ith up to 200 mg, with slightly less than dose‐proportional increases doses >200 mg. Plasma had biphasic...