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Healthy Volunteers clinical trials

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NCT ID: NCT01406158 Completed - Healthy Volunteers Clinical Trials

A Study in Healthy Volunteers Comparing Two Different Liquid Formulations of Solifenacin With Each Other and With the Tablet Formulation

Start date: May 2011
Phase: Phase 1
Study type: Interventional

A study in healthy volunteers comparing two different liquid formulations of solifenacin with each other and with the tablet formulation.

NCT ID: NCT01402076 Completed - Healthy Volunteers Clinical Trials

A Study to Assess the Effect Tasimelteon on the Cytochrome P450 3A4 and 2C8 Enzymes in Healthy Subjects

Start date: August 2011
Phase: Phase 1
Study type: Interventional

The purpose of this research study is to understand whether there is any difference in the amount of midazolam (including its breakdown product) in the blood when midazolam is given with tasimelteon, and whether there is any difference in the amount of rosiglitazone in the blood when rosiglitazone is given with tasimelteon.

NCT ID: NCT01399385 Recruiting - Healthy Clinical Trials

New Heart Imaging Techniques to Evaluate Possible Heart Disease

Start date: July 6, 2011
Phase: N/A
Study type: Interventional

Background: - Imaging tests, such as magnetic resonance imaging (MRI), can provide information about heart and blood vessels. The tests let doctors can see the amount of blood vessel narrowing and vessel wall thickness. This information may help diagnose and treat heart disease and other conditions that lead to heart attacks. Better MRI methods are needed to improve heart disease diagnosis, especially by avoiding the use of radiation. Researchers are testing new techniques to improve the quality of heart MRI, compared with more complex studies like catheterization or angiography. Objectives: - To compare heart MRI techniques with other tests used to diagnose heart disease. Eligibility: - People at least 18 years of age who either have or may have heart disease, or are healthy volunteers. Design: - Participants will be screened with a physical exam, medical history, and blood tests. - They will have an angiography to study the inside of blood vessels. This test is an x-ray study of the blood vessels. It will be done either separately or as part of a set of tests to diagnose possible heart disease. - Participants will have at least one and up to five MRI scans. The scans will involve different methods of studying the heart and blood vessels. Participants may also have a computed tomography scan to confirm the findings of an MRI scan. - No treatment will be provided as part of this protocol.

NCT ID: NCT01398293 Completed - Healthy Volunteer Clinical Trials

A Study of Danoprevir in Combination With Low-Dose Ritonavir in Healthy Subjects

Start date: August 2011
Phase: Phase 1
Study type: Interventional

This single-dose, randomized, double-blind, double-dummy, placebo-controlled, positive-controlled four-way crossover study will evaluate the effect of a single dose of danoprevir with low-dose ritonavir on the QC/QTc interval in healthy volunteers. Subjects will be randomly assigned to one of four sequences with treatments of A: therapeutic dose of danoprevir plus ritonavir (DNV/r), B: supratherapeutic dose of DNV/r, C: moxifloxacin and D: placebo, with a washout period of at least 7 days between treatments.

NCT ID: NCT01398241 Completed - Healthy Volunteer Clinical Trials

A Study of RO5267683 in Healthy Subjects

Start date: August 2011
Phase: Phase 1
Study type: Interventional

This investigator-blind, subject-blind, randomized, placebo-controlled study will evaluate the safety, pharmacokinetics and pharmacodynamics of multiple ascending doses of RO5267683 in healthy volunteers. Subjects will be randomized to receive either RO5267683 or placebo orally daily for 28 days. Follow-up will be 10 weeks after the last dose.

NCT ID: NCT01397604 Completed - Healthy Volunteers Clinical Trials

The Effects of GLA on Human Volunteers

Start date: July 2011
Phase: Phase 1
Study type: Interventional

The advent of vaccines contributed to major improvements in human morbidity and mortality due to infectious diseases such as polio, small pox, measles and diphtheria. However infectious diseases like HIV, malaria and tuberculosis continue to be major causes of death worldwide and conventional vaccine strategies have not been successful. The fundamental problem is that current protein based vaccines do not elicit the necessary T-cell immunity. Experimentally, adjuvants can be given in conjunction with a vaccine to activate and mature the dendritic cell (DC), which can then direct an immune response to enhance T-cell immunity. One family of potential adjuvants functions through the activation of Toll-like receptors (TLR) on the DC. Major gaps exist in our understanding of adjuvant effects in humans. We hypothesize that a synthetic adjuvant directed to activate TLR4 (GLA) will safely stimulate the innate immune system when administered subcutaneously (SC) or intramuscularly (IM). Importantly, in contrast to other adjuvant trials in which adjuvant is combined with an antigen or vaccine, GLA will be tested in isolation. This is because we anticipate the future administration of GLA with our dendritic cell targeted HIV vaccine. A DC-targeted vaccine cannot be given without an immune stimulating adjuvant due to potential risk of inducing immune tolerance. Therefore, in order to understand the specific contributions of GLA versus the DC-targeted vaccine, we need to understand the GLA effects in isolation. The safety and tolerability of 2 different formulations of GLA (GLA-SE vs. GLA-AF) administered by 3 different routes (SC, ID, IM) will be the major focus of this trial. The second focus will be characterizing the innate immune response by assessing systemic cytokine and chemokine levels and determining global gene regulation following GLA stimulation. The third focus will be on the cellular effects of GLA, specifically on blood monocytes and dendritic cells. Monocytes may represent a large pool of inducible potent DC (monocyte-derived DC), however these cells have not been well characterized in humans. We will investigate the effects of GLA stimulation on the peripheral blood monocyte subsets that might give rise to monocyte-derived DC.

NCT ID: NCT01397071 Completed - Healthy Volunteers Clinical Trials

Effects of Avocado When Added to a Meat Patty on Inflammation in Healthy Men

Start date: August 2011
Phase: N/A
Study type: Interventional

Avocados are naturally rich in antioxidants, or beneficial compounds, that can help prevent many diseases, like atherosclerosis (hardening of the arteries). When foods that are high in fats are eaten, certain harmful compounds can be absorbed, which can lead to atherosclerosis. One harmful compound is called malondialdehyde, or MDA. This compound can be measured in the blood and the urine after a person eats a high fat meal. Antioxidants found in herbs and spices may lower the absorption of MDA, which could help prevent the development of atherosclerosis. This study will determine whether the beneficial compounds of avocado can reduce absorption of MDA. This will be tested by asking healthy males to eat a high fat ground beef patty with or without avocado and then measuring the amount of MDA in their blood and urine samples. Blood flow will also be measured. Healthy men have been chosen for this study because eating high fat hamburger patties can easily mimic in them the condition that causes atherosclerosis. Avocados are rich in antioxidants, which have been shown in previous studies to reduce the absorption of harmful compounds, like MDA, that are formed during cooking. The results from this study may help to explain how high fat foods can be harmful to the body and how beneficial antioxidants from herbs and spices can protect the body. This will be determined from blood and urine samples after the subjects are given two different meals: a) a plain cooked ground beef patty, and b) or avocado with a cooked ground beef patty.

NCT ID: NCT01395108 Completed - Healthy Volunteers Clinical Trials

Clinical Study on Oral Nemonoxacin Malate Capsules

Start date: January 2008
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of nemonoxacin in healthy Chinese volunteers.

NCT ID: NCT01394757 Completed - Healthy Volunteers Clinical Trials

Network Dysfunction, Schizophrenia and Pharmacological Magnetic Resonance Imaging (phMRI)

Start date: August 2011
Phase: N/A
Study type: Interventional

Alterations of functional brain networks have been frequently demonstrated in schizophrenia, although the exact underlying molecular mechanisms remain unrevealed. Ketamine is known to exert its schizophrenia-like effects through modulation of the glutamatergic system, thus facilitating the investigation of the impact of this specific transmitter system on resting state functional brain networks. The aim of the study is therefore to use pharmacological functional Magnetic Resonance Imaging (phMRI) to examine changes in brain networks involved in schizophrenia in response to ketamine application compared to placebo. 30 healthy subjects (15 females) will be examined twice using a double-blind, placebo-controlled, randomized, crossover, counterbalanced-order design. Resting state fMRI will be investigated before, during and after either placebo or ketamine intravenous infusion for 20 minutes. Prior to the main trial 10 additional participants will be included in an open pilot trial. Hypothesis: Ketamine application will induce changes in resting state networks previously associated with schizophrenia and in the connectivity of relevant brain regions such as the striatum, thalamus, caudate, hippocampus and amygdala. Furthermore, the application of ketamine will provoke changes in the BOLD-activation in three fMRI paradigms each performed before and after ketamine infusion.