View clinical trials related to Healthy Subjects.
Filter by:The study will be a 3-way crossover design: it will assess the impact of consuming a beverage enhanced with satiety-relevant properties on subjective ratings of appetite and on energy intake compared with a low energy version with the same sensory characteristics, and a non-sensory enhanced high energy control. In addition, saliva samples will be collected at regular intervals for the identification of novel biomarkers of energy intake.
This is an open-label, single-dose, randomized crossover study of single oral 10-mg tablet doses administered either after an overnight fast or in combination with a standard high-fat meal in healthy subjects.
This study will be a single center, open-label, drug-drug interaction study in healthy male and female subjects. The study will consist of 2 parts. In Part A, the effects of steady-state dosing of a strong CYP3A inhibitor (itraconazole) or inducer (rifampin) on the pharmacokinetics of E2006 and metabolites will be assessed. Approximately 30 subjects will be sequentially assigned to 1 of 2 treatment groups to receive itraconazole or rifampin in equal numbers (approximately 15 subjects per group). The itraconazole treatment group will be fully enrolled before enrollment is initiated for the rifampin treatment group. In Part B, the effects of steady-state dosing of E2006 on the pharmacokinetics of midazolam, a substrate of CYP3A, plus bupropion, a substrate of CYP2B6, will be assessed in approximately 24 subjects. The 2 study parts can be conducted in parallel.
This study will assess the effect of multiple doses of fidaxomicin on the single dose pharmacokinetics of rosuvastatin in healthy male subjects. Determine the safety and tolerability of multiple doses of fidaxomicin in the presence of a single dose of rosuvastatin in healthy male subjects. Also determine the pharmacokinetics of multiple doses of fidaxomicin and its metabolite OP-1118.
Mind-Body Awareness Training (MBAT), in the forms of various yoga and meditative practices, has become increasingly prevalent due to an increase in awareness of the potential health benefits, and improvements in concentration that this training can provide to practitioners. In the present study, we investigate the role of Mind-Body Awareness Training (MBAT) in the initial learning of a sensorimotor (SMR) based Brain-Computer Interface (BCI). The PI's hypothesis is that MBAT will improve performance in SMR based BCI.
RPX7009(beta-lactamase inhibitor) is being studied in combination with a carbapenem (RPX2014) to treat bacterial infections, including those due to multi-drug resistant bacteria.
This is a first time in human study to assess the safety and tolerability of AZD1979 following oral administration of single ascending doses in healthy male volunteers. Pharmacokinetics (what the body does to the drug) parameters will also be assessed as secondary objectives.
Study hypothesis Aleurone-rich food supplementation modifies cardiovascular and metabolic risk profiles and gut microbiota in subjects with high BMI Primary objectives of the trial are to evaluate whether wheat Aleurone-rich food supplementation modifies (1) fasting homocysteine levels; (2) human biofluid primary metabolites; (3) human biofluid secondary (microbiota-derived) metabolites; (4) fecal bile acid and fecal sterol concentrations. Secondary objectives are to evaluate whether wheat Aleurone-rich food supplementation modifies (1) fecal microbiota, (2) plasma and urine MS based metabolite profiling; (3) total cholesterol, triglycerides, LDL- and HDL-cholesterol levels; (4) serum glucose and insulin levels; (5) anthropometric indices; (6) urinary isoprostane levels; (7) markers of intestinal permeability in plasma; (8) inflammation Study Design Placebo-controlled, randomized, double-blind parallel trial Criteria for Enrollment Inclusion criteria: Aged 18-65 years; BMI >27 kg/m^2. Good General health. Exclusion criteria: Fasting blood glucose >300 mg/dl; triglycerides >500 mg/dl; uncontrolled hypertension (blood pressure [BP] >160/100 mm Hg under antihypertensive therapy); any long term medical therapy; food intolerances; alcohol intake >5 drinks per day or use of narcotic substances; use of dietary supplements, pro or pre- biotics; special diet; pregnancy, tobacco smoking. Methodology After a run-in phase of two weeks, participants will be randomized to receive supplementation with either wheat Aleurone-rich food (27 g Aleurone/day) or placebo for 4 weeks in a double-blind manner. Clinical visit, clinical tests, and blood drawing will be performed after an overnight fasting at the start of the run-in phase (visit T-1) at U.O.S. di Dietetica e Nutrizione Clinica, St Chiara, Trento. Clinical tests, blood drawing, and stool and urine collection will be performed during visits at the beginning and end of each treatment period (T0 and T1) at U.O.S. di Dietetica e Nutrizione Clinica, St chiara, Trento. A 4 day-food diary record will be collected before visits T0 and T1. Efficacy Assessments Arterial BP; BMI; ratio of waist to hip circumference; food questionnaires; blood sample analysis (total cholesterol, triglycerides, HDL and LDL cholesterol, serum glucose and insulin, C-RP, plasma LPS, LPS specific IgG, CD14, LPS-binding protein); urinary isoprostane; urinary and plasma metabolite profiling; fecal microbiota analysis. Safety Assessments. Adverse events. Statistical analyses. Post-intervention data will be compared by ANOVA using the General Linear Model with baseline as a covariate. Data with a skewed distribution will be log transformed before analyses. Simple and multiple linear regression will be used to determine relationships between variables and independent t-tests performed to evaluate differences in reported compliance between groups. Results will be expressed as mean +/- SEM and differences will be considered significant at P < 0.05.. Duration of Dosing. Subjects will make three visits during the study (start of run-in phase - visit T-1-, beginning - visit T0, week 2 - and end of treatment period - visit T1, week 6). Duration of the treatment period is four weeks; a daily Aleurone consumption of 27 g is targeted.
The purpose of this study is to evaluate the pharmacokinetics of 14C-labeled cleavage product (BAL8728), in particular the routes of excretion and extent ot metabolism of the cleavage product following administration of a single intravenous dose of pyridinylmethyl-14C-labeled prodrug isavuconazonium sulfate (BAL8557). In addition, identify the metabolic profile of BAL8728 in human plasma, urine and/or feces after a single intravenous dose of pyridinylmethyl-14C-labeled BAL8557 and evaluate the pharmacokinetics of BAL8728 and BAL4815. Safety and tolerability after a single intravenous dose of pyridinylmethyl-14C-labeled isavuconazonium sulfate will also be evaluated.
This study will be a single-center, open-label, drug-drug interaction study in healthy male and female subjects. The study will consist of 3 parts: A, B, and C. In Part A, the effect of itraconazole or rifampin on the pharmacokinetics (PK) of E2609 and metabolites will be assessed. Approximately 32 subjects will be assigned to 1 of 2 treatment groups (itraconazole or rifampin) in equal numbers, with approximately 16 subjects per group. In Part B, the effects of steady-state dosing of E2609 on the PK of digoxin will be assessed in approximately 18 subjects. In Part C, the effects of donepezil administered in combination with, or 2 hours after, E2609 dosing on the PK of E2609 and metabolites, will be assessed in approximately 24 subjects.