View clinical trials related to Healthy Volunteers.
Filter by:Nanoparticles (NPs) are minute pieces of material to which we are exposed every day in the air we breathe. Some are naturally occurring and have no impact on health, whereas others are produced from urban air pollution and can worsen diseases, particularly in the lungs and blood vessels. However, there is great interest in developing new NPs because of their unique properties that are useful for many applications, such as engineering, electronics and for drug delivery. At present it is unclear exactly what effects inhaled NPs have. Our current programme of research is designed to assess whether a specialized group of fats made in the body (called eicosanoids) drive the cardiovascular effects of NPs. The changes in the profiles of these fats will provide unique fingerprints that could be used to predict the actions of new NPs. In the proposed clinical study we shall investigate the effects of both environmental and manufactured carbonaceous NPs on the lungs, blood vessels, blood clotting, and levels of eicosanoids in blood and urine. We have previously investigated the cardiovascular effects of carbon nanoparticles after inhalation in man, and these experiments will investigate how the shape, size and composition of carbon particles influence these responses. These experiments will provide new insight into how NPs affect the body and pave the way for new ways to predict the toxic effects of NPs (reducing the need for animal experiments). The findings will enable the design of novel NP without the harmful characteristics of those found in air pollution.
This is an open-label, non-randomized, successive cohorts design, multicenter, single dose phase I study. The primary objectives are: - to evaluate the pharmacokinetics (plasma and urine) profile of P03277 following single intravenous injection (0.1 mmol/kg body weight) in patients with mild to severe renal impairment and in healthy volunteers with normal renal function used as reference. - to assess dialysability of P03277 following a single intravenous injection (0.1 mmol/kg body weight) in patients with end stage renal disease requiring hemodialysis.
The study is a Phase I, Single center, Randomized, Cross-over Double-blind Placebo-controlled and Open-label Positive-controlled (moxifloxacin) in healthy volunteers. The primary objective is to assess the cardiac safety after administration of P03277 to 48 healthy volunteers at dose of 0.1 mmol/kg (anticipated clinical dose) and 0.3 mmol/kg (supra-clinical dose) by evaluating the QT and QTc intervals.
The purpose of this study is to learn about a drug-drug interaction. When two medications are taken together at the same time, one medication may change the activity of the other medication in the body - this is called a drug-drug interaction. This study is looking at the effect the Bayer study drug, copanlisib, has on metformin, a commonly used medication to treat diabetes. During the study, blood and urine samples will be collected and analyzed to learn about pharmacokinetics (how copanlisib changes metformin levels in the body) and pharmacodynamics (the effect metformin has on the body when taken together with copanlisib) when someone takes both copanlisib and metformin together.
The ID-Cap System is classified as an ingestion event marker (IEM), a Class II medical device. The system is intended to record time-stamped ingestions with the ingestible sensor, ID-Tag which transmits a signal to a wearable device, the ID-Cap Reader. In this study, 12-18 subjects will ingest capsules containing ingestible sensors while wearing the Reader and being observed in a clinic setting.
Background: Dopamine is a natural chemical in the brain that may influence eating behavior and physical activity. Researchers want to measure the brain s dopamine activity and understand how it differs in people with obesity. Objective: To better understand how brain function, particularly dopamine activity, relates to body weight and eating behavior. Individuals may be able to participate if they: Have a BMI of at least 18.5 kg/m2 Are weight-stable and generally healthy Are between ages 18-45 years Have normal blood pressure Are not using illegal drugs (based on urine drug screen) Are not following a special diet Do not have metal implants Design: Participants will be screened with: - Medical history - Physical exam - Questionnaires and an interview to see if it is safe to have a PET/MRI scan - Fasting blood and urine tests - Participants will eat a special diet given to them for the 5 days before their inpatient visit. Participants will have a 5-day inpatient visit. Some days include blood and urine tests. Each day includes surveys and tests to measure habits and likes/dis-likes. A sample schedule may be: Day 1: Participants will wear a monitor that uses a needle below the skin to measure glucose. Their body fat will be measured with low-dose x-rays Day 2: Participants will have a PET scan. They will lie on a table that slides in and out of a donut-shaped scanner. They will be injected with a small amount of a radioactive substance and wear a cap on their head. Day 3: Participants will have an MRI. They will lie on a table that slides in and out of a scanner. Day 4: Participants will have another PET scan. This time, they will drink a milk shake during a break from the scanner. Then, they will go back inside the scanner for the end of their scan. Day 5: Participants will wear a hood for up to 40 minutes to measure their breathing. They will also drink special water and collect samples of their urine to measure the rate they burn energy. For 12 months after the visit, participants will track their weight and physical activity daily using a special scale and activity monitor. A few times over the year, the study team will send participants special activity monitors to use for 7 days at a time. Participants will have an in-person 1-day follow-up visit. This includes most tests except for PET scanning....
The primary objective of the study is to evaluate the safety and tolerability of single ascending doses of REGN5069 administered intravenously (IV) and subcutaneously (SC) in healthy male and female participants. The secondary objectives of the study are to characterize the pharmacokinetics (PK) profile of single IV and SC doses of REGN5069 in healthy participants and assess the immunogenicity of REGN5069 in healthy participants administered single IV or SC doses of REGN5069
The purpose of this study is to evaluate the effect of ozanimod after repeated dosing on blood pressure and heart rate response to a single-dose administration of pseudoephedrine (PSE) in healthy adult subjects. Study Design This is a Phase 1, randomized, double-blind, placebo-controlled study. Approximately sixty eligible subjects will be enrolled and randomized in a 1:1 fashion with 30 subjects in each treatment group. Subjects will receive placebo or ozanimod once daily (QD) for 30 days. On Day 30, a single oral dose of pseudoephedrine (PSE) 60 mg will be co-administered with placebo or ozanimod. Study Population The study will enroll approximately 60 healthy men and non-pregnant, non-lactating women, ages 18 to 55 years, inclusive, with a body weight of at least 110 pounds (50 kg) and body mass index within the range of 18.0 to 30.0 kg/m2, inclusive. Length of Study The study duration is 65 ± 2 days.
Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C] ASN002 Following a Single Oral Dose in Healthy Male Subjects
Phase 1 study designed to evaluate the relative bioavailability of a single dose of a test formulation, DSM265-TPGS 34% SDD powder in comparison with a reference DSM265 25% SDD powder formulation used in early clinical trials.