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Healthy Subjects clinical trials

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NCT ID: NCT01302158 Completed - Healthy Subjects Clinical Trials

Drug-drug Interaction Study With ASP1941 and Glimepiride

Start date: December 2009
Phase: Phase 1
Study type: Interventional

A study to investigate the effect of ASP1941 on the pharmacokinetics and safety of glimepiride (Part A) and to investigate the effect of glimepiride on the pharmacokinetics, safety and pharmacodynamics of ASP1941 (Part B).

NCT ID: NCT01302132 Completed - Healthy Subjects Clinical Trials

Mass Balance Study of ASP1941

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

This study investigates the pharmacokinetics, in particular the routes and extent of metabolism and excretion, of ASP1941 after a single oral dose.

NCT ID: NCT01297062 Completed - Healthy Subjects Clinical Trials

A Safety Study to Assess the Effects of Therapeutic and Supratherapeutic Exenatide Concentrations on QT Interval in Healthy Subjects

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

Compare the effect of exenatide (therapeutic and supratherapeutic concentrations), moxifloxacin and placebo on the QT interval.

NCT ID: NCT01297023 Completed - Healthy Subjects Clinical Trials

Human Intervention Study With Calcium Phosphate and Vitamin D

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

The study was conducted to investigate the effect of vitamin d3 alone and in combination with calcium phosphate on bone metabolism and further physiological parameters in healthy subjects. It is postulated that calcium phosphate beneficially influences the bone specific action of vitamin d3.

NCT ID: NCT01281995 Completed - Healthy Clinical Trials

Effects of Systemically Administered Hydrocortisone on the Immune System in Healthy Volunteers

Start date: January 21, 2011
Phase:
Study type: Observational

Background: - Corticosteroids have been used to treat inflammation and immune system diseases for decades. However, despite their widespread use, there is little information on the specifics of how corticosteroids affect the immune system in humans. The Center for Human Immunology, Autoimmunity, and Inflammatory Diseases is interested in studying how the steroid hormone hydrocortisone affects the immune system in healthy volunteers, and in doing so to understand how hydrocortisone given at different doses works in treating many immune and inflammatory conditions. Objectives: - To evaluate the effects of hydrocortisone on the immune and inflammatory responses of healthy volunteers over the short and intermediate term (up to 28 days after administration). Eligibility: - Healthy volunteers at least 18 years of age. Design: - Participants will be screened with a full medical history and physical examination, and blood and urine tests. At this visit, participants will be separated into two groups, with each group scheduled to receive a different amount of hydrocortisone during the study visit. - One week before the study visit, participants will provide a blood sample for baseline testing. - Participants will be admitted for a 24-hour inpatient stay that will involve frequent blood draws. Between blood draws, participants will be able to work, watch TV, walk around, and so on, and will be provided with regular meals. - Blood will be drawn 1 hour before the infusion of hydrocortisone. Participants will be divided into two further sets of groups with different blood draw schedules: - Groups 1 (lower dose) and 2 (higher dose) will have blood draws 1, 4, 8, 12, and 24 hours after the hydrocortisone infusion. - Groups 3 (lower dose) and 4 (higher dose) will have multiple blood draws over 24 hours, with timing based on data from the previous groups blood test results. - Participants will provide additional blood samples 7 and 28 days after the in-patient visit....

NCT ID: NCT01261156 Completed - Healthy Subjects Clinical Trials

A Study to Evaluate the Effects of Diltiazem, a Moderate CYP3A4/A5 Inhibitor, on the Pharmacokinetics and Pharmacodynamics of E5555 and Its Metabolites in Healthy Subjects

Start date: October 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the effects of diltiazem on the pharmacokinetics (PK) and pharmacodynamics (PD) of E5555 and its metabolites in healthy subjects.

NCT ID: NCT01260155 Completed - Healthy Subjects Clinical Trials

A Single-Center, Open-Label, Randomized, 3-Treatment Crossover Bioavailability Study of Single Oral Doses of E5501 Old Tablet Formulation Under Fasted Conditions and a New Tablet Formulation Under Fed and Fasted Conditions in Healthy Subjects

Start date: January 2010
Phase: Phase 1
Study type: Interventional

This study will be a single-center, open-label, randomized, 3-treatment crossover bioavailability study of single oral doses of E5501 old tablet formulation under fasted conditions and a new tablet formulation administered under fed and fasted conditions in healthy subjects.

NCT ID: NCT01258491 Completed - Healthy Subjects Clinical Trials

Study to Investigate the Pharmacodynamics, Pharmacokinetics and Safety of a Single Oral Repeated Dose of 500 mg Nicotinic Acid as Tablets in Healthy Subjects

Start date: May 2005
Phase: Phase 1
Study type: Interventional

The study will be a double-blind, randomized, placebo-controlled, single-center, 2 treatment,3-way crossover to investigate the pharmacodynamics, i.e. the flush-symptom of a single oral repeated dose of 500 mg nicotinic acid in healthy subjects. Subjects will be randomly allocated to a treatment sequence - AAB, ABA or BAA. The two treatments will be: - Treatment A: 500 mg nicotinic acid - Treatment B: Placebo

NCT ID: NCT01251887 Completed - Obesity Clinical Trials

Dietary Essential Fatty Acid Regulation of Omega-3 HUFA Metabolism; Satiety and Body Composition

Start date: November 12, 2010
Phase: N/A
Study type: Interventional

Background: - Rates of obesity have increased dramatically in recent decades, and researchers are investigating how changes in diets and physical activity have contributed to this increase. To understand how weight might be controlled, it is important to learn what kinds of dietary changes can affect hunger and might lower body weight. Essential fatty acids, for instance, are an important part of a healthy diet, but researchers have not yet determined the ideal amount of essential fatty acids that people should eat. By studying how different diets affect body chemistry and hormone levels in women who are overweight or obese, researchers hope to be able to determine better diets or treatments to help people reach and maintain an optimum healthy weight. Objectives: - To examine how certain fats in the diet affect body metabolism, hormones, and weight regulation. Eligibility: - Healthy women between 18 and 50 years of age who are overweight or obese (body mass index between 25 and 35). Design: - This study has an initial screening visit and three phases. All participants will be involved in the first two phases of the study, and some participants will be involved in the third phase. - Participants will be screened with a physical examination and medical history, in addition to blood and urine tests and questionnaires about eating habits and other diet factors. - Phase 1: Participants will have three visits to the National Institutes of Health over a 4-week period. At the visits, participants will have blood and urine tests, complete questionnaires, and have other tests including brain and body imaging studies. Participants will then be assigned to one of three study diets. - Phase 2: Participants will have a 12-week diet phase, with all foods supplied by the study researchers. Participants will keep a daily log of food and beverage intake, and will have three testing sessions with procedures similar to those performed in Phase 1. - Phase 3: Participants assigned to a particular study diet (one-third of all participants) will be given the option of continuing the diet for an additional 36 weeks (9 months), with food consumption, monitoring, and testing procedures similar to those performed in Phase 2....

NCT ID: NCT01251731 Completed - Healthy Subjects Clinical Trials

Single and Multiple Dose Asian Bridging Study

Start date: July 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the single-dose (SD) pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of 10, 40, and 80 mg E5501 followed by a selected dose for multiple dosing (MD) in healthy Japanese, Chinese, and Caucasian subjects.