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Showing "Study MCAF5352A Healthy Volunteers" PubMed Articles 1–25 of 62,000+

Measurement of IL-17AA and IL-17FF as Pharmacodynamic Biomarkers to Demonstrate Target Engagement in the Phase I Study of MCAF5352A.

The interleukin (IL)-17 pathway has been implicated in the pathophysiology of many autoimmune diseases. MCAF5352A is a humanized monoclonal antibody which targets both IL-17A and IL-17F, thereby inhibiting the activity of IL-17 dimers (IL-17AA, IL-17AF, and IL-17FF). The pharmacokinetic profile of MCAF5352A has been characterized in both a Phase Ia single ascending dose study and a Phase Ib multiple ascending dose study. Two qualified enzyme-linked immunosorbent assays were used to measure total IL-17AA and...

Healthy volunteers' perceptions of risk in US Phase I clinical trials: A mixed-methods study.

There is limited research on healthy volunteers' perceptions of the risks of Phase I clinical trials. In order to contribute empirically to long-standing ethical concerns about healthy volunteers' involvement in drug development, it is crucial to assess how these participants understand trial risks. The objectives of this study were to investigate (1) participants' views of the overall risks of Phase I trials, (2) their views of the risk of personally being harmed in a trial, and (3) how risk perceptions va...

First population pharmacokinetic analysis showing increased quinolone metabolite formation and clearance in cystic fibrosis patients compared to healthy volunteers.

Understanding the pharmacokinetics in cystic fibrosis (CF) patients is important for dosing. For antibiotics with extensive metabolism, however, a comparison of metabolite formation and elimination between CF-patients and healthy volunteers has never been performed via population modeling. We aimed to compare the population pharmacokinetics of fleroxacin and its N‑oxide and demethyl metabolites between CF-patients and healthy volunteers. Our analysis included eleven adult CF-patients and twelve healthy vo...

Exceptional Risk: Healthy Volunteers' Perceptions of HIV/AIDS Clinical Trials.

As with all early-stage testing of investigational drugs, clinical trials targeting HIV/AIDS can pose unknown risks to research subjects. Unlike sick participants seeking a therapeutic benefit, the motivations and barriers for healthy volunteers are more complex and understudied. Drawing on interviews and clinical trial data from 178 healthy volunteers, we examine how they perceive HIV/AIDS studies in the early stages of testing. A subset of healthy volunteers see phase I HIV/AIDS studies as particularly ri...

Ultrasound dynamics of gastric content volumes after the ingestion of coconut water or a meat sandwich. A randomized controlled crossover study in healthy volunteers.

Adequate preoperative fasting is critical in preventing pulmonary aspiration of gastric content. We proposed to study the sonographic gastric content dynamics after the ingestion of liquid or solid food in healthy volunteers and confront it with current guidelines for preoperative fasting times.

Pre-treatment with sumatriptan for cilostazol induced headache in healthy volunteers.

Previous studies indicate that sumatriptan is not effective when second messenger levels are high as after cilostazol provocation. Therefore, we have conducted the present study, where sumatriptan is administrated as pretreatment before cAMP increases due to cilostazol intake. Our hypothesis was that pretreatment with sumatriptan would have a significant effect against cilostazol induced headache in healthy volunteers.

FGF-21 levels in polyuria-polydipsia syndrome.

The pathomechanism of primary polydipsia is poorly understood. Recent animal data reported a connection between fibroblast growth factor 21 (FGF-21) and elevated fluid intake independently of hormonal control by the hormone arginine-vasopressin (AVP) and osmotic stimulation. We therefore compared circulating FGF-21 levels in patients with primary polydipsia to patients with AVP deficiency (central diabetes insipidus) and healthy volunteers. In this prospective cohort study, we analyzed FGF-21 levels of 20 p...

Red cell distribution width and common disease onsets in 240,477 healthy volunteers followed for up to 9 years.

Higher Red Blood Cell Distribution Width (RDW or anisocytosis) predicts incident coronary artery disease (CAD) plus all-cause and cardiovascular mortality, but its predictive value for other common diseases in healthy volunteers is less clear. We aimed to determine the shorter and longer term associations between RDW and incident common conditions in participants free of baseline disease, followed for 9 years. We undertook a prospective analysis of RDW% using 240,477 healthy UK Biobank study volunteers aged...

Physiologically-Based Pharmacokinetic Modelling to Predict Exposure Differences in Healthy Volunteers and Subjects with Renal Impairment: Ceftazidime Case Study.

Ceftazidime is a widely used β-lactam antibiotic and almost entirely excreted via glomerular filtration in kidney. The objective of this analysis was to assess the ability of physiologically-based pharmacokinetic (PBPK) model to predict ceftazidime exposure in healthy volunteers and subjects with renal impairment. A full PBPK model of ceftazidime was developed using physiochemical properties and clinical data. The total clearance of 115 mL/min and renal clearance of 100 mL/min were obtained from ceftazidim...

Safety and Pharmacokinetics of Standardized Extract of Centella asiatica (ECa 233) Capsules in Healthy Thai Volunteers: A Phase 1 Clinical Study.

The aim of this study was to investigate the safety and pharmacokinetic profiles of a newly developed, standardized extract of (ECa 233) capsule in healthy Thai volunteers. This study was designed as an open-labeled, 2-sequence dosage, single- and repeated-dose study investigated under fasting conditions. Plasma concentrations of the parent compounds and their relative acid metabolites were measured and pharmacokinetic parameters were calculated using noncompartmental analysis. Tolerability was assessed ba...

Opioid-Induced Reductions in Gait Variability in Healthy Volunteers and Individuals with Knee Osteoarthritis.

To investigate differences in gait variability induced by two different single-dose opioid formulations and an inert placebo in healthy volunteers and knee osteoarthritis patients.

Left atrial functional response after a marathon in healthy amateur volunteers.

Middle-aged marathon runners have an increased risk of developing atrial fibrillation (AF). A previous study described that repetitive marathon running was associated with left atrial (LA) dysfunction. However, whether this change is common in marathon runners and which runners are at risk of LA dysfunction remain unknown. The purpose of this study was to determine which factors could predict LA dysfunction. We prospectively examined 12 healthy amateur volunteers (9 males, 31 ± 8 years old) who partic...

Relative and Absolute Bioavailability Study of Emicizumab to Bridge Drug Products and Subcutaneous Injection Sites in Healthy Volunteers.

Emicizumab (ACE910) is a bispecific antibody that is a novel, subcutaneously injectable treatment for patients with hemophilia A. This study assessed the relative bioavailability of emicizumab between old and new drug products (DPs) and among 3 commonly used subcutaneous injection sites (abdomen, upper arm, and thigh), together with its absolute bioavailability in healthy volunteers. Forty-eight healthy volunteers were randomized into 4 groups to receive a single subcutaneous injection of 1 mg/kg with the o...

Does sensorimotor incongruence trigger pain and sensory disturbances in people with chronic low back pain? A randomised cross-over experiment.

Chronic low back pain (CLBP) has major public health implications and underlying mechanisms are still unclear. Sensorimotor incongruence (SMI) - an ongoing mismatch between top down motor output and predicted sensory feedback - may play a role in the course of chronic non-specific low back pain. The hypothesis of this study was that the induction of SMI causes sensory disturbances and/or pain in people with CLBP and healthy volunteers. A sample of 66 people (33 people with CLBP and 33 healthy volunteers) pa...

On-the-road driving performance the morning after bedtime administration of lemborexant in healthy adult and elderly volunteers.

To assess potential effects of lemborexant on next-morning driving performance in adult and elderly healthy volunteers.

A validated LC-MS/MS method for simultaneous determination of linagliptin and metformin in spiked human plasma coupled with solid phase extraction: Application to a pharmacokinetic study in healthy volunteers.

Combination therapy has a pivotal role in type II diabetes mellitus management in patients unable to maintain normal glycemic level using metformin alone. Addition of linagliptin, dipeptidyl peptidase-IV inhibitor, to metformin improves glycemic control. This study is concerned with the development of an HPLC-MS/MS method for simultaneous quantification of linagliptin and metformin in spiked human plasma. The method was applied to evaluate the potential pharmacokinetic interactions between the cited drugs i...

Application of Photoacoustic Methods and Confocal Microscopy for Monitoring of Therapeutic Response in Plaque Psoriasis.

Psoriasis is prone to relapses and requires long-term therapy that may induce a range of adverse effects; therefore, an efficient and early detection of relapses is desirable. In this study, photoacoustic imaging and confocal laser scanning microscopic (CLSM) methods were investigated for their suitability in psoriasis follow-up examinations. Using a high-resolution photoacoustic system, the vascular structures of 11 psoriatic patients and 6 healthy volunteers were investigated. No differences were detected...

Heat-induced extracellular HSP72 release is blunted in elderly diabetic people compared with healthy middle-aged and older adults, but it is partially restored by resistance training.

Recent evidence suggests that the anti-inflammatory heat shock response (HSR) is reduced in aging and diabetes. In this study we compared HSR between healthy middle-aged adults, healthy elderly and type 2 diabetic (T2DM) elderly, and tested whether resistance training (RT) could improve the HSR in T2DM group. Thirty sedentary participants volunteered for this study. HSR (assessed as the capacity to export HSP72 during heat stress) was measured in the blood and compared between the groups. HSR was similar be...

Novel Compound Induces Erythropoietin Secretion through Liver Effects in Chronic Kidney Disease Patients and Healthy Volunteers.

TP0463518 is a novel hypoxia-inducible factor prolyl hydroxylase inhibitor developed to aid in the treatment of anemia associated with chronic kidney disease (CKD) and is expected to increase erythropoietin (EPO) derived from liver. Two phase I studies were conducted in healthy volunteers (HV) and CKD patients undergoing hemodialysis (i.e., HD patients) or those not undergoing dialysis (i.e., ND patients).

Fibromyalgia patients and healthy volunteers express difficulties and variability in rating experimental pain: a qualitative study.

Background and aims Despite the enormous body of literature spanning more than 50 years describing results of pain experiments, very few have used qualitative methods to explore subjects' thoughts while scoring experimental painful stimuli, and none in the available literature have used qualitative interviews to do so. The current study examined how participants in experimental pain research delineate pain ratings to better understand the unique influences of the experimental setting on pain scores. An addi...

Population Pharmacokinetic Modelling of Ceftazidime and Avibactam in the Plasma and Epithelial Lining Fluid of Healthy Volunteers.

Our objective was to develop population pharmacokinetic (PK) models for ceftazidime and avibactam in the plasma and epithelial lining fluid (ELF) of healthy volunteers and to compare ELF concentrations to plasma PK/pharmacodynamic (PD) targets.

The effect of smoking cessation on posterior ocular structures.

This study evaluated changes in cho-roidal and macular thickness in healthy volunteers and chronic smokers.

Effect of single caffeine intake on neuropsychological functions in healthy volunteers: A double-blind placebo-controlled study.

We investigated the effects of a single instance of caffeine intake on neurocognitive functions and driving performance in healthy subjects using an established cognitive battery and a driving simulator system.

Chewing gum for 1 h does not change gastric volume in healthy fasting subjects. A prospective observational study.

Perioperative fasting guidelines differ in their approaches to chewing gum in the preoperative period. Current recommendations range from canceling the surgery to proceeding with it. Given this lack of consensus, we performed gastric ultrasound assessments in healthy volunteers before and after a standardized period of chewing gum. The objective of our study was to determine if chewing gum for 1 h change the gastric volume.

Single- and Multiple-dose Pharmacokinetics and Safety of Pimodivir, a Novel, Non-Nucleoside Polymerase Basic Protein 2 Subunit Inhibitor of the Influenza A Virus Polymerase Complex, and Interaction With Oseltamivir: A Phase 1 Open-Label Study in Healthy Volunteers.

Evaluate the drug-drug interaction between pimodivir, a novel, non-nucleoside polymerase basic protein 2 (PB2) subunit inhibitor of the influenza A virus polymerase complex, and oseltamivir, to assess the feasibility of this combination therapy. Furthermore, single- and multiple-dose pharmacokinetics and safety of pimodivir in healthy volunteers were assessed.

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