View clinical trials related to Healthy Volunteers.
Filter by:The purpose of this study is to estimate phosphodiesterase 10A (PDE10A) occupancy in brain following a single dose of TAK-063.
The purpose of this study is to assess the safety, tolerability, and the effect of food on KQ-791. Each participant may receive up to 3 single doses of KQ-791 (at up to 3 different dose levels) and 1 placebo dose over the course of the study. Up to 6 escalating dose levels may be studied, in two distinct groups or cohorts.
This double-blinded randomized clinical trial investigates any differences in allergic responses elicited by Bee Venom (BV) and Essential Bee Venom (eBV).
Background: The drug Roflumilast (Daliresp) is used to treat Chronic Obstructive Pulmonary Disease (COPD). COPD is a lung disease that makes it difficult to breathe. Studies have shown that this drug decreased the blood sugar of people with type 2 diabetes. Sitagliptin (Januvia) is a medication presently used to treat diabetes. Researchers think that both of these drugs may decrease blood sugar by causing an increase in the hormone GLP-1.This hormone is secreted in the small intestines and stomach and is also known as an incretin. Researchers want to study how these drugs affect blood sugar, insulin, and other hormones in the blood. Objectives: - To study the effects of Roflumilast (Daliresp) and Sitagliptin (Januvia) on blood sugar and insulin. - To better understand GLP-1 and other gut hormones. This may lead to new treatments for type 2 diabetes. Eligibility: - Healthy volunteers age 21 55. - Body Mass Index (BMI) less than 30 Design: -This study will require one screening visit and four study visits, scheduled about 3-weeks apart. Screening visit requires participants to arrive after fasting for 10 hours and have the following: - Medical history, physical exam, height, weight, blood pressure measurements and blood and urine tests. - A 2-hour oral glucose tolerance test (OGTT). Participants will drink an orange-flavored drink containing 75 grams of sugar (300 calories). A blood sample will be taken prior to drinking the beverage and 2-hours later. - An electrocardiogram (EKG) to measure the electrical activity of the heart. - Questionnaires about risk for depression or suicide. Study visits 1to 4: - Participants will arrive the evening prior and blood work will be done to confirm eligibility. They will not eat or drink anything except water starting at 8:00 p.m. - About 6:30 a.m. the following day, an I.V. (small plastic tube) will be placed in an arm vein and used to take 20 blood samples over a period of about 11 hours. - Participants will receive one of the following study medication/placebo groupings in random order: 1. Roflumilast (Daliresp) 500 mcg pill; and 1 placebo pill 2. Sitaglipitin (Januvia) 100 mg pill; and 1 placebo pill 3. Roflumilast (Daliresp) 500 mcg pill; and Sitagliptin (Januvia) 100 mg pill 4. 2 placebo pills - One hour later, they will have a 10-hour mixed meal test (MMT). They will be asked to drink a nutritional shake (Ensure Plus). Blood samples will be taken over the next 10 hours to measure blood sugar, insulin and other hormones. At the end of the test, they will be given a meal. - Participants will answer questions about side effects and symptoms. They will receive a follow-up phone call within 10 days.
Sub-Study: Phase Triggered Paired Associative Stimulation (PAS) (actively recruiting) Background: -Previous research has shown that the brain s activity changes with changes in brain waves. We can study brain activity with a procedure called transcranial magnetic stimulation (TMS), a form of non-invasive brain stimulation. EEG allows for measuring ongoing brain waves. The goal of this study is to optimize TMS delivery by utilizing EEG-triggered TMS. Objectives: -To see if changes in brain waves change the brain and body s response to TMS. Eligibility: -Healthy, right-handed adults age 18-35. Design: - Participants will be screened under another protocol with medical history and physical exam. They may take a pregnancy test. They will have a magnetic resonance imaging (MRI) scan of the brain. For MRI, participants lie on a table that slides in and out of a metal tube that takes pictures. with: - Participants will have up to 4 outpatient visits lasting 2-3 hours each (4 outpatient visits). The following procedures may occur at a visit: - Magnetic resonance imaging (MRI): Participants lie on a table that slides into a machine that takes pictures of the brain. - Electroencephalography (EEG): Small electrodes on the scalp record brain waves. - Electromyography (EMG): Small sticky electrodes on the skin measure muscle activity. - Transcranial magnetic stimulation (TMS): A wire coil is held to the scalp. A brief electrical current passes through the coil and affects brain activity. Main Study: Influence on Plasticity of Brain Temperature (no longer recruiting) Background: - Brain activity changes with changes in body temperature. Brain activity can be studied with a procedure called transcranial magnetic stimulation (TMS). Researchers want to cool the brain through the scalp using a cooling cap. They want to see if cooling changes the brain and body s response to TMS. Objectives: - To look at the effects of cooling on the brain. Eligibility: - Right-handed adults age 18-50 who can abstain from caffeine and tobacco. Design: - Participants will be screened with medical history and physical exam. They will be asked about alcohol use, smoking, and substance abuse. They may take a pregnancy test. They may have a magnetic resonance imaging (MRI) scan of the brain. For MRI, participants lie on a table that slides in and out of a metal tube that takes pictures. - Participants will have 3 outpatient visits. The following procedures will occur at each visit. - Participants will wear a cooling cap for up to 45 minutes. Cool water will flow through the cap. It will feel like an ice pack in a towel. Their core temperature will be monitored. Their temperature will also be measured under their tongue and on scalp, stomach, forearm, and calf. - Participants will have TMS before and after wearing the cap. A brief electrical current will pass through a wire coil held on their scalp. Electrodes that detect muscle movement will be placed on their hand. They will also have repetitive TMS, which uses repeated magnetic pulses. Their wrist will also receive a shock.
Four periods of oral dosing following overnight fasting (1. known metabolic probe drug cocktail consisting of caffeine, diclofenac, esomeprazole, metoprolol, midazolam; 2. dabigatran + cocktail; 3. dabigatran alone; 4. clarithromycin 3 days + cocktail + dabigatran). Blood samples collected for pharmacokinetics over 24 h. Washout between periods. Adverse events, haematology and clinical chemistry recorded.
The purpose of this study is evaluate the safety and tolerability of single and multiple ascending oral doses of ASP6858. This study will also evaluate the pharmacokinetics (PK) of ASP6858 and its metabolites as well as the effect of food to the PK of ASP6858. The study will also evaluate the pharmacodynamics of ASP6858.
The study will determine the magnitude and duration (time to resolution i.e., returning to normal ranges) of elevations in the following coagulation test results after a single 1200 mg dose of oritavancin: Prothrombin Time/International Normalized Ratio (PT/INR), Activated clotting time (ACT), Activated Partial Thromboplastin Time (APTT), Chromogenic Factor Xa Assay, D-dimer, Silica Clot Time and Dilute Russell's Viper Venom Time (DRVVT).
This will be a single center, open-label study in healthy male subjects between 18 and 45 years old to determine the dose response profiles of dermal blood flow in response to intradermal injections of maxadilan. The study will consist of 2 parts: Part I: dose and time finding and Part II: reproducibility over time.
The purpose of this study is to evaluate safety, pharmacokinetics and pharmacodynamics of single subcutaneous injection of MT203 in healthy adult Japanese and Caucasian male participants