A5019793347- Inflammatory mediators and NSAID effects
- Antibiotics Pharmacokinetics and Efficacy
- Analytical Methods in Pharmaceuticals
- Immune Response and Inflammation
- Antiplatelet Therapy and Cardiovascular Diseases
- Drug Transport and Resistance Mechanisms
- Pharmacogenetics and Drug Metabolism
- Pain Mechanisms and Treatments
- Atrial Fibrillation Management and Outcomes
- Pharmacological Effects and Toxicity Studies
- Heart Rate Variability and Autonomic Control
- Chronic Obstructive Pulmonary Disease (COPD) Research
- Cardiac Arrhythmias and Treatments
- Blood Pressure and Hypertension Studies
- Pharmacology and Obesity Treatment
- Immune Cell Function and Interaction
- Opioid Use Disorder Treatment
- Neuroscience of respiration and sleep
- Venous Thromboembolism Diagnosis and Management
- Anesthesia and Pain Management
- Anesthesia and Sedative Agents
- High Altitude and Hypoxia
- Asthma and respiratory diseases
- Multiple Myeloma Research and Treatments
- Mechanical Circulatory Support Devices
Duke Medical Center
2012-2020
Duke University
2009-2020
American College
2002-2019
Duke University Hospital
2017-2018
Johns Hopkins Medicine
2018
Johns Hopkins University
2018
Clinical Research Institute
2016
Daiichi-Sankyo (South Korea)
2012
Eisai (Japan)
2012
Chiesi (France)
2012
Edoxaban, an oral direct factor Xa inhibitor, is in development for thromboprophylaxis, including prevention of stroke and systemic embolism patients with atrial fibrillation (AF). P-glycoprotein (P-gp), efflux transporter, modulates absorption excretion xenobiotics. Edoxaban a P-gp substrate, several cardiovascular (CV) drugs have the potential to inhibit increase drug exposure.To assess pharmacokinetic interactions edoxaban 6 used management AF known substrates/inhibitors.Drug-drug...
Of the new direct oral anticoagulants, factor Xa inhibitors are limited by absence of a proven reversal agent. We assessed safety, tolerability and impact on anticoagulation ciraparantag (PER977) alone following 60 mg dose FXa inhibitor edoxaban. Escalating, single IV doses were administered edoxaban in double-blind, placebo-controlled fashion to healthy subjects. Serial assessments pharmacokinetics pharmacodynamic effects performed. Eighty male subjects completed study. Following (60 mg),...
E5564 is a second-generation synthetic analogue of the lipid A component endotoxin (lipopolysaccharide [LPS]). The ability to block toxic activity LPS was assessed in double-blind, placebo-controlled study. bolus infusion (4 ng/kg) administered healthy subjects induce mild transient syndrome similar clinical sepsis. Single doses 50–250 μg ameliorated or blocked all effects dose-dependent manner. All dose groups had statistically significant reductions elevated temperature, heart rate,...
Particle size distribution is a major determinant of particle clearance by the mononuclear phagocytic system and potential for concomitant activation resident macrophages. To test safety second-generation perflubron-based emulsion (60% perfluorocarbon [PFC] wt/vol; Oxygent™ [Alliance Pharmaceutical Corp., San Diego, CA]) with small mean size, two parallel, randomized, double-blinded, placebo-controlled studies were conducted in 48 healthy volunteers (n = 24 per study). The study described...
Rationale: Anxiety is a common comorbidity of chronic obstructive pulmonary disease (COPD) that associated with higher morbidity and mortality. We evaluated three anxiety screening questionnaires: the Generalized Disorder 7-Item Scale (GAD-7), Hospital Depression subscale (HADS-A), Inventory for Respiratory Disease (AIR).Objectives: To evaluate compare test performance characteristics questionnaires, using Mini-International Neuropsychiatric Interview (MINI), version 7.0, as "gold...
Background C‐reactive protein ( CRP ) binds to damaged cells, activates the classical complement pathway, is elevated in multiple inflammatory conditions, and provides prognostic information on risk of future atherosclerotic events. It controversial, however, as whether inhibiting synthesis would have any direct anti‐inflammatory effects humans. Methods Results A placebo‐controlled study was used evaluate ISIS 329993 ‐ R x acute‐phase response after endotoxin challenge 30 evaluable subjects....
Aims To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of edoxaban, an oral direct factor Xa inhibitor, in healthy subjects switching from warfarin. Methods Seventy‐two were randomized to edoxaban 60 mg once daily ( n = 48) or matching placebo 24) for 5 days at 24 h after last dose warfarin treatment INR 2.0 3.0). Safety/tolerability was primary outcome measure. Pharmacokinetics, , aPTT, anti‐FXa thrombin generation other coagulation assays assessed. Results 64...
Spontaneous intracranial hemorrhage (ICH) remains a devastating stroke subtype, affecting as many 80,000 people annually in the United States and associated with extremely high mortality. In absence of any pharmacological interventions demonstrated to improve outcome, care for patients ICH largely supportive. Thus, despite advances understanding brain injury, there an unmet need that neurologic recovery outcomes. Recent research suggesting inflammation APOE genotype play role modifying...
The adjuvanted respiratory syncytial virus (RSV) prefusion F protein-based vaccine (RSVPreF3 OA) is approved in adults aged ≥60 years. We evaluated RSVPreF3 OA immunogenicity and safety 50-59 years without or with increased risk for RSV disease due to specific chronic medical conditions.
Previous perfluorocarbon (PFC) emulsions have been associated with transient adverse events (i.e., platelet activation, decreased count, febrile responses, changes in hemodynamic function). The Phase I studies described this report were parallel, randomized, double-blinded, placebo-controlled conducted 48 healthy volunteers (n = 24 per study) perflubron emulsion (Oxygent™; Alliance Pharmaceutical Corp., San Diego, CA). Because of the counts observed previous PFC and intended use surgical...
Celecoxib is a novel cyclooxygenase-2-specific inhibitor for the management of acute pain, primary dysmenorrhea, and signs symptoms arthritis. This double-blind, placebo-controlled study in 16 healthy volunteers evaluated whether celecoxib alters effect concomitant aspirin on platelet function. Volunteers received (400 mg/day) or placebo 4 days. On day 5, they also single 325 mg dose with either 200 placebo. Thromboxane aggregation response to adenosine 5'-diphosphate (ADP), collagen,...
Summary Administration of anagrelide, an antiplatelet agent, to ten normal male subjects was accompanied by asymptomatic fall in platelet count. The drop gradual and usually occurred within two weeks. Only a slight shortening survival seen. Bone marrow morphology appeared normal. Measurement production rates showed reduced response thrombocytopenia. A substantial increase the percentage large platelets observed drug treated subjects. These observations are compatible with selective...
Abstract The effects of various single oral doses micronized benzbromarone on serum and urinary uric acid oxypurines were studied in 5 healthy volunteers patients with gout. There was an effective, unequivocal, dose‐related reduction levels both groups. simultaneous increased excretion but not suggests the mechanism effect is uricosuria. prolonged duration action up to 48 hours after dosing advantageous as drug need be taken only once a day. data presented favor protracted trial gout hyperuricemia.
The oral anticoagulant edoxaban, a factor Xa inhibitor, will likely be coadministered with digoxin in some patients atrial fibrillation. Both drugs are substrates for P–glycoprotein. objective of this phase 1, parallel study was to assess the effects coadministration both on their respective pharmacokinetics (PK) and pharmacodynamics (PD). Forty-eight subjects, ages 18 45 years, received either edoxaban 60 mg qd × 7 days (n = 24) or 0.25 bid 2 5 then concomitantly days. Serial blood urine...
This study evaluated the short-term effects of tofacitinib treatment on peripheral blood leukocyte phenotype and function, reversibility any such following withdrawal in healthy volunteers. Cytomegalovirus (CMV)-seropositive subjects received oral 10 mg twice daily for 4 weeks were followed after drug withdrawal. There slight increases total lymphocyte T-cell counts during treatment, B-cell increased by up to 26%. no significant changes granulocyte or monocyte counts, function. Naïve central...
Methylphenidate hydrochloride (HCl) is frequently used for the treatment of attention deficit/hyperactivity disorder (ADHD). A study was conducted in healthy subjects to evaluate dose‐ranging pharmacokinetics 18, 36, and 54 mg methylphenidate HCl delivered using an oral, osmotic, controlled‐release formulation (OROS®). Plasma concentrations l‐ were 40‐fold lower than those d‐ methylphenidate, whereas plasma d‐α‐ phenyl‐2‐piperidine acetic acid ( PPA) PPA, major metabolite comparable. Mean...