View clinical trials related to Healthy Volunteers.
Filter by:The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of ascending multiple oral doses of ASP3700 in healthy subjects.
Background: - Drinking grapefruit juice changes how long it takes some medicines to be broken down in the body. Researchers have found that a substance in grapefruit juice called DHB contributes to this effect. Some dietary supplements contain DHB and claim to increase the absorption of any and all supplements, medicine or any other drug. But these usually contain a lot more DHB than a glass of grapefruit juice. Researchers want to study the effects of grapefruit juice and supplements with DHB. Objective: - To compare how a certain dietary supplement (sold as DHB-300 ) versus grapefruit juice affects how long it takes a person s body to break down medicines. Eligibility: - Healthy volunteers ages 18 - 60. Design: - Participants will be screened with medical history, physical exam, and blood and urine tests. - Participants will have 3 treatment visits. Participants cannot drive themselves home from the visits. Each visit lasts about 13.5 hours and includes: - Questions about medications and participant s health. - Vital signs taken. - A finger probe to measure oxygen. - Blood and urine sampling throughout the visit. - An IV line inserted into an arm vein. It will stay there throughout the visit. - Study treatments: - Midazolam hydrochloride a syrup given to make people sleepy. - Loperamide a tablet for treating diarrhea. - 1 glass of water, 1 glass of grapefruit juice, or 1 pill of DHB-300. A different one will be given at each treatment visit. - One week before each visit, participants cannot have certain fruits and juices. They must fast the night before each visit. - For the 3 days after each visit, participants will return to the clinic 4 times. Their vital signs will be checked and blood will be drawn.
Type 1 diabetes mellitus (T1DM) develops when there is impaired insulin production due to loss of insulin producing cells (beta cells). The amount of insulin that can be produced is imperfectly correlated with beta cell mass (BCM). The development of a reliable method to noninvasively quantify the total amount of insulin producing beta cells would be of great benefit by providing an important endpoint for the development of new treatments of diabetes. The investigators have previously identified a specific marker on islet cells called vesicular monoamine transporter 2 (VMAT2) that the investigators now propose to use in positron emission tomography (PET) scanning to determine islet beta cell mass. The PET radiopharmaceutical 18F-fluoropropyl(FP)-dihydrotetrabenazine(DTBZ) has been used previously in human subjects without adverse effects. It has shown promise in differentiating type 1 diabetes and non-diabetes. The investigators now hypothesize that repeat PET scans will be reproducible in the same subject. Subjects with normal BCM will be recruited from among normal weight non-diabetic people with plasma insulin levels within the normal range. Subjects with predicted reduced BCM will be recruited from among patients with T1DM who have low or non-measurable insulin levels. Two PET scan measurements will be taken in each subject and the amount of VMAT2 in the pancreas will be and compared for reproducible findings. Biochemical testing will also be performed and compared to PET scans as a potential indirect marker of beta cell mass.
Background: - Many people can lose weight by changing their diet or exercise. However, most people eventually regain the weight over time. This weight regain may be related to changes in metabolism as well as changes in the brain caused by weight loss. Researchers want to learn more about these changes. Objective: - To see how weight loss and regain affects the body s metabolism and the brain of obese but healthy adults. Eligibility: - Obese but healthy adults age 18-55 who plan to participate in a weight loss program at one of several participating clinics or resorts. Design: - Participants will first be screened at home through questionnaires and telephone interviews. - Participants will then be screened at the NIH with blood tests, medical history, physical exam, electrocardiograms, and questionnaires. They will have a mock magnetic resonance imaging (MRI) scan. - At visit 1, participants will stay at the NIH and will: - have MRI and PET brain scans. - have body composition scans and measurements. - give blood samples. - eat a special diet. - wear a physical activity monitor. - provide a urine sample and body weight daily. - drink a special type of water to measure calorie burn. - wear a clear plastic hood over their head while lying down, to collect exhaled air. - spend 24 hours in a room that measures oxygen and carbon dioxide. - complete questionnaires and computer tasks. - After visit 1, participants will give daily urine samples and weight and physical activity measurements from home. Then they will follow a lifestyle intervention for weight loss and give daily weight and activity measurements. - Visits 2, 3, and 4 occur 1-26 months after the start of the weight loss program. Participants will repeat procedures from visit 1. Visits 1-4 last 4 days each. - Researchers will track participants weight and physical activity for up to 26 months after visit 2.
A medical device study to assess the clinical accuracy and equivalence to reference devices of the SVSS to satisfy the requirements of the recognised applicable international standards.
This research study is looking at how imatinib affects how dasatinib is absorbed and eliminated from the body. Both imatinib and dasatinib are in a class of medications called tyrosine kinase inhibitors (TKI) and they are used to treat certain types of leukemia (cancer that begins in the white blood cells). Both imatinib and dasatinib have been given safely in healthy volunteers. In this study investigators will evaluate the pharmacokinetics interaction between imatinib and dasatinib when they are co-administered. The hypothesis is that imatinib will increase the blood levels of dasatinib through inhibiting the drug metabolizing enzyme and efflux transporter that are involved in the dasatinib absorption and removal. This research will provide important new insight of combination TKI therapy in terms of transporter- and enzyme- mediated pharmacokinetic interactions. The research results will also help guide doctors in knowing how much of a tyrosine kinase inhibitor to give safely while reaching best effect in TKI combination therapy.
This is a study designed to look at how arousal levels in the brain change with age and how these changes influence thinking, vision, hearing and physical function in people of advanced age.
This will be a single-center, open-label, inpatient/outpatient, fixed-sequence study examining the effect of multiple doses of bitopertin on single doses of Midazolam in healthy volunteers. A single oral dose on Midazolam (7.5 mg) will be administered on Day 1 after an overnight fast. Daily oral doses of bitopertin will be given under fed conditions from Days 2-13 and after fasting on Day 14. Oral doses of bitopertin and Midazolam (7.5 mg) will be co-administered on Day 15, after an overnight fast. Pharmacokinetics will be assessed throughout. Total time on treatment is expected to be 15 days.
The purpose of the study is to assess the safety, tolerability and pharmacokinetics of AZD4316 following oral administration of single and multiple doses to healthy volunteers.
Background: - The experience of volition that accompanies voluntary movement can be divided into the sense of will, or deciding to move, and the sense of agency, or feeling that the movement just made was self-generated. Very little is known regarding the neurological origin of this sense of volition. Previous research has shown that a particular part of the brain, the parietal lobe, is involved in our inner sense that we control the movements we make. Researchers are interested in determining if this sense relies on sensory information from moving fingers reaching the parietal lobe. Objectives: - To determine the brain regions responsible for the sense of volition and the associated sense of agency. Eligibility: - Healthy right-handed individuals between 18 and 55 years of age. Design: - The study will involve a screening visit and two testing visits. The screening visit will last 30 minutes to 1 hour, and the testing visits will each last 3 to 4 hours. - Participants will be screened with a physical examination and medical history. - At each testing visit, participants will have a brain magnetic resonance imaging (MRI) scan, electroencephalography (EEG), and electromyography (EMG). The MRI scan and EEG will be done during a movement task that involves the thumb, second finger, and fifth finger of one hand. EMG will be used to monitor movements and muscle activity. - During the second testing visit, participants will receive a nerve block using anesthetic, followed by the MRI, EEG, EMG and movement task. The nerve block will temporarily numb and prevent the movement of parts of the hand and fingers. - After the MRI scan and EEG recording, participants will be asked to rate how much control they felt they had over choosing whether to move, and how much control they felt they had in actually making the movements.