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Healthy Volunteers clinical trials

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NCT ID: NCT02363335 Completed - Healthy Volunteers Clinical Trials

The Role of Phosphodiesterase Inhibitors in Incretin Secretion

Start date: February 13, 2015
Phase: Phase 1
Study type: Interventional

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.

NCT ID: NCT02361619 Completed - Healthy Volunteers Clinical Trials

Dabigatran in an Interaction Probe Drug Cocktail

D-cocktail
Start date: February 2015
Phase: Phase 1
Study type: Interventional

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.

NCT ID: NCT02359032 Completed - Healthy Volunteers Clinical Trials

A Combined Single and Multiple Ascending Dose Study of ASP6858 in Healthy Subjects

Start date: January 2015
Phase: Phase 1
Study type: Interventional

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.

NCT ID: NCT02357524 Completed - Healthy Volunteers Clinical Trials

Oritavancin on the Results of Multiple Coagulation Tests in Healthy Volunteers

Start date: January 2015
Phase: Phase 1
Study type: Interventional

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).

NCT ID: NCT02355756 Completed - Healthy Volunteers Clinical Trials

Biomarker Development for Future PAC1 Antagonists With Maxadilan

Start date: January 2015
Phase: Phase 0
Study type: Interventional

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.

NCT ID: NCT02351804 Completed - Healthy Volunteers Clinical Trials

Does Perineural Dexamethasone Prolong Duration of a Nerve Block?

Start date: February 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate whether dexamethasone as an adjuvant to ropivacaine for adductor canal block increases duration of the sensory block, when controlling for a systemic effect using a paired design and bilateral blocks. The investigators hypothesize that adding dexamethasone to ropivacaine will prolong block duration compared with ropivacaine + placebo.

NCT ID: NCT02347969 Completed - Healthy Volunteers Clinical Trials

Evaluation of the Effect of the Dietary Supplement X34 on Skin Radiance of Healthy Volunteers With Dull Complexion

Start date: October 2014
Phase: N/A
Study type: Interventional

The main objective of this trial is to evaluate the effect of the daily dose of X34 dietary supplement on skin radiance (clinical assessment) for 8 weeks.

NCT ID: NCT02346812 Completed - Healthy Volunteers Clinical Trials

Brassica Intake and Isothiocyanate Absorption

Start date: January 2015
Phase: N/A
Study type: Interventional

Healthy individuals (n=18) will participate in 2 controlled-feeding study periods that are 3 weeks each in length: 1) Control diet 2) Brassica diet. The control diet will consist of typical American foods and will be free of Brassica vegetables and free of glucosinolates and isothiocyanates. The Brassica diet will contain the control diet plus glucosinolate/isothiocyanate treatment foods. There will be a break of 3 weeks in between study periods. Blood, urine, and fecal samples will be collected at the end of each study period. Eligible participants will be selected based on genotype for glutathione S-transferase (GST), which has been shown to influence the potential protective role of dietary Brassicas. Half the participants (n=9) will be GSTM1-positive individuals and half (n=9) will have the GSTM1-null genotype.

NCT ID: NCT02342938 Completed - Healthy Volunteers Clinical Trials

Simultaneous MEG or fMRI And INtracranial EEG

SEMAINE
Start date: September 16, 2013
Phase: N/A
Study type: Interventional

The SEMAINE project will investigate intracranial EEG (icEEG) simultaneously recorded with either fMRI or MEG to 1) improve identification of the epileptogenic zone in patients suffering from drug-resistant partial epilepsy, and 2) define the functional organization of neural networks underlying human perception and cognition in order to prevent inadvertent deficits resulting from neurosurgical resection. In particular, high-frequency activity (HFA), as measured with icEEG, has been demonstrated in recent years as a relevant index for both epileptogenic tissue and healthy cortical processing, but its correlates in fMRI and MEG require further investigation. This will be a pioneering effort in several respects, as the first to directly measure high-frequency neural activity in tandem with fMRI, and among the first to do so with MEG. In addition to their attractiveness as noninvasive imaging techniques, fMRI and MEG have the potential to examine whole-brain networks that are not accessible to icEEG's necessarily limited spatial coverage. Furthermore, such a campaign of simultaneous recordings will take unprecedented advantage of icEEG as the bridge between the two noninvasive techniques, providing compelling evidence for the links between all three measurements with respect to underlying high-frequency neural activity in both health and disease. This project will therefore lead to improved selection of epilepsy surgery candidates and improved neurosurgical outcomes from the precise mapping of epileptogenic and healthy brain networks. The same techniques will be immediately applicable to functional mapping of other types of neurosurgery populations as well as diagnostic neuroimaging of neurological and psychiatric populations.

NCT ID: NCT02342925 Completed - Healthy Volunteer Clinical Trials

A Study of the Effect of RG1662 on Metformin in Healthy Volunteers

Start date: February 2015
Phase: Phase 1
Study type: Interventional

This single-center, non-randomized, open-label, two treatment, two period, fixed sequence crossover study will investigate the effect of RG1662 treatment on the activity of key renal transporters in healthy male and female participants using metformin. The effect of RG1662 on other renal function parameters will also be explored.