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Healthy Volunteers clinical trials

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NCT ID: NCT01864876 Completed - Healthy Volunteers Clinical Trials

The Effects of GLA (5 mcg) on Human Volunteers

Start date: September 2012
Phase: Phase 1
Study type: Interventional

This protocol is for a phase 1, randomized, single-blinded study to evaluate the safety and tolerability of a single 5 mcg dose of GLA-SE administered intramuscularly and GLA-AF administered subcutaneously. The second focus will be to detail the global immune response by measuring systemic cytokines, chemokines, and global gene regulation. The third focus will be to investigate the effects of GLA on the peripheral blood immune cells including monocytes and dendritic cells. The results of this trial will generate supportive human data to use GLA as an adjuvant in a dendritic cell-targeted vaccine strategy.

NCT ID: NCT01864226 Completed - Healthy Volunteer Clinical Trials

A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO5545965 in Healthy Volunteers

Start date: June 2013
Phase: Phase 1
Study type: Interventional

This single-center, randomized, investigator/subject-blind, adaptive multiple ascending-dose, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO5545965 in healthy volunteers. Subjects will be randomized to receive either RO5545965 or matching placebo daily for 12 days.

NCT ID: NCT01861964 Completed - Healthy Volunteers Clinical Trials

Effects of Xylooligosarcharide on Composition of the Human Colonic Microflora

XOS
Start date: February 2012
Phase: Phase 2/Phase 3
Study type: Interventional

Human and animal studies demonstrate that xylooligosaccharides (XOS) are a highly efficacious prebiotic ingredient that delivers benefits at a minimum level of 1.4 g/day (d), which is much lower than levels required by fructooligosaccharides (FOS, 5 g/d) or galactooligosaccharides (GOS, 8 g/d). XOS promotes gastrointestinal regularity and relieves diarrhea and constipation at 0.7 g/d and 1.4 g/d, respectively. Xylooligosaccharides may also reduce blood cholesterol and may improve glycemic control, although more data from clinical trials are needed to confirm preliminary findings.

NCT ID: NCT01861626 Completed - Healthy Volunteers Clinical Trials

Bioequivalence Study of V0057 Versus a Reference Formulation After Single Administration in Healthy Male Subjects

Start date: May 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the bioequivalence (comparison of the rate and extent of the active substance into the body following single administration of the drugs) between the test product V0057 and a reference product after two single oral administration separate by 7 days.

NCT ID: NCT01859377 Completed - Healthy Volunteers Clinical Trials

Evaluation and Comparison of Systemic Exposure to Ibuprofen After Single Oromucosal Versus Oral Administrations

Start date: May 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the systemic exposure to ibuprofen after single oromucosal administration of the test product V0498 and single oral administration of a reference product.

NCT ID: NCT01859078 Completed - Healthy Volunteers Clinical Trials

A Drug Drug Interaction (DDI) Study of Baricitinib (LY3009104) and Digoxin in Healthy Participants

Start date: May 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the effect of baricitinib on the levels of digoxin in the blood stream and how long it takes the body to remove digoxin. This study will also look at how safe and well-tolerated baricitinib is when given at the same time as digoxin in healthy participants. This study will last approximately 3-4 weeks.

NCT ID: NCT01855048 Completed - Healthy Volunteers Clinical Trials

A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of N-Rephasin® SAL200 in Healthy Male Volunteers

Start date: August 6, 2013
Phase: Phase 1
Study type: Interventional

The Objectives of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of single dose of N-Rephasin® SAL200 in healthy male subjects.

NCT ID: NCT01854710 Completed - Healthy Volunteers Clinical Trials

ADASUVE 2-dose Thorough QT/QTc Study

Start date: May 2013
Phase: Phase 4
Study type: Interventional

Assess the potential effects on the QT interval of 2 consecutive doses of ADASUVE administered 2 hours apart, in relation to placebo and an active control in healthy volunteers.

NCT ID: NCT01851421 Terminated - Obesity Clinical Trials

Fat Metabolism and Melanocortin 3 Receptors in African Americans

Start date: September 23, 2013
Phase:
Study type: Observational

Background: - Melanocortin receptors are proteins in the body that help send messages between body systems. One such receptor, the melanocortin 3 receptor (MC3R), is important for regulating body weight. Differences in MC3R can affect fat metabolism - or how the body handles fat. Some people who have changes in the MC3R genetic code are heavier than those who do not have these changes. These changes are found more often in African Americans. Researchers want to study the MC3R in African American adults to see how these changes may affect fat metabolism. They will look at overweight adults with either the most common genetic code for the MC3R or a rare variant. Objectives: - To study the role of the MC3R in body weight and fat metabolism. Eligibility: - Healthy African American volunteers between 18 and 55 years of age. - Volunteers must be overweight (body mass index at least 30 kg/m2) but weigh less than 450 lbs. Design: - The study consists of an outpatient screening visit and a 7-day inpatient visit with dietary studies. - Participants will be screened with a physical exam and medical history. Blood samples will be collected. (Participants will need to fast for 10 hours before giving blood samples.) A body scan will be given to determine fat, bone, and muscle content. Participants will complete a 3-day dietary assessment to record their food and drink consumption. They will also have an exercise test to look at heart and lung function. - Participants will have a 7-day inpatient stay. They will have a regular diet for the first 3 days of the study. For the final 4 days, they will have a diet with a higher fat content. - During the inpatient visit, participants will have the following study procedures: - Body measurements - Daily exercise routine - Imaging studies of the body - Measurement of a whole day s energy expenditure (spending one day in metabolic chamber-day 5) - Frequent blood samples - Urine collection for 24 hours (days 3 and 7) - Fat biopsy (collection of a small sample of fat tissue from under the skin on the abdomen) - Insulin and metabolism tests while eating the two different diets (day 4 and day 7). - After the final insulin and metabolism test, participants will be discharged from the study.

NCT ID: NCT01851382 Completed - Healthy Volunteer Clinical Trials

Collection of Saliva and/ or Peripheral Blood From Healthy Volunteers for Research

Start date: May 15, 2013
Phase:
Study type: Observational

Background: - Researchers often collect samples from healthy volunteers to further their research. These samples can help better understand serious side effects and complications of transplant treatments in patients. This study will collect saliva samples from healthy volunteers. Objectives: - To collect saliva and blood samples from healthy volunteers for research studies. Eligibility: - Healthy men ages 30-70 years for Phase I of the study. Design: - Participants will be screened with a medical history questionnaire. They will also have a brief oral exam to check for any mouth infection. - Participants will provide a saliva sample. The collection process will take about 5 minutes. - No treatment will be given as part of this study.