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Healthy Volunteers clinical trials

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NCT ID: NCT01573429 Completed - Healthy Volunteers Clinical Trials

Bisphenol A Controlled Exposure Study

Start date: July 18, 2012
Phase: Phase 1
Study type: Interventional

Background: - Bisphenol A (BPA) is a chemical that is used primarily to make plastics, resins, and thermal paper. Most people are exposed daily to low levels of BPA that leaches into food and water from plastic products, including water and baby bottles. However, not all of the risks of BPA are known. Researchers want to learn more about how BPA acts in the body, and how the body gets rid of BPA. Objectives: - To study controlled exposure to BPA and its effects on the body. Eligibility: - Healthy, non-obese volunteers between 25 and 45 years of age. Design: - Participants will have six visits over about 2 to 4 weeks for this study. - At the first visit, participants will be screened with a physical exam and blood and urine tests. They will complete a questionnaire about exposure to BPA-containing products. They will also receive a list of medications that should not be taken during the study period. - The second visit will last about 13 hours. Participants will fast for 8 hours before the visit. They will then have a single dose of d-BPA (a modified form of BPA that is easier to study in the body). Regular blood samples will be taken over the 13-hour visit. All urine will also be collected. Participants will receive breakfast and lunch during the visit. - Participants will have four follow-up visits. They will collect and store all of their urine between each follow-up visit. Blood samples will be collected at the follow-up visits....

NCT ID: NCT01571570 Completed - Healthy Volunteers Clinical Trials

A Study to Assess Bioavailability & Food Effect of Different Liquid and Capsule Formulations of TMC435.

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

The purpose of this study is to evaluate the relative bioavailability and the short-term safety and tolerability of TMC435 following administration of 3 single oral doses of 150 mg, given as different formulations in healthy adult participants. In addition, this study is to assess for the acceptability of the taste of both liquid formulations.

NCT ID: NCT01569828 Completed - Healthy Volunteer Clinical Trials

Multiple Dose Pharmacokinetics of LCZ696 and Its Metabolites in Subjects With Severe Renal Impairment vs. Matched Healthy Subjects With Normal Renal Function

Start date: March 2009
Phase: Phase 2
Study type: Interventional

An open label, parallel-group study to determine multiple dose pharmacokinetics of LCZ696 and its metabolites in subjects with severe renal impairment compared to matched healthy subjects with normal renal function

NCT ID: NCT01569126 Completed - Healthy Volunteer Clinical Trials

A Study of LY110140 in Healthy Japanese Male Participants

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

The purposes of this study are to look at safety, how well the study drug (LY110140) is tolerated, and how much of the study drug gets into the blood stream when given as single dose (SD) and multiple doses (MD) to healthy Japanese male participants. Participants will participate in SD portion for approximately 6 weeks and in MD portion for approximately 10 weeks.

NCT ID: NCT01568697 Recruiting - Healthy Subjects Clinical Trials

Oral Bacteria and Immune System Problems Involved in Gum Disease (Periodontitis)

Start date: October 5, 2012
Phase:
Study type: Observational

Background: - Gum disease is a condition in which the tissue around the tooth root becomes swollen and infected. This condition can cause tooth loss if it is not treated. Who gets gum disease and how bad it will be depends on (1) the different bacteria in the mouth and (2) how the immune system of an individual handles these bacteria. Researchers want to look at the oral bacteria and genetic immune problems of different people to learn how these affect gum disease and other conditions of the mouth. Objectives: - To study how immune system problems may lead to problems in the mouth, including gum disease. Eligibility: - Children and adults at least 7 years of age who have genetic problems with their immune system. - Healthy adults that have periodontal disease - Health adults that do not have periodontal disease Design: - This study will involve a screening visit and a study visit. - Participants will be screened with a medical history, blood work and a full oral and dental exam, including dental x-rays and photos. - The study visit will involve collection of blood, urine, and other samples, including saliva, plaque, and gum swabs. Any abnormal tissue will sampled for a biopsy. Additional oral and dental exams will be performed. Participants will also answer questions about any current medical or dental problems.

NCT ID: NCT01565720 Completed - Healthy Volunteers Clinical Trials

Study of the Effect of Repeat Doses of Isavuconazole on Cardiac Repolarization

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

This study is designed to evaluate repeat doses of isavuconazole on cardiac repolarization in healthy adult subjects. Eligible subjects will be randomized to one of four treatment groups and be confined for 17 days including pre-dosing days. Moxifloxacin will be given as an active control on the last dosing day to healthy subjects in one of the four groups. All treatments, except the moxifloxacin dose, are double-blinded (neither the subject nor the study doctor will know the treatment assignment). Subjects will undergo continuous ECGs on three study days. ECGs, vital signs, blood draws will be obtained throughout the study for safety and to assess the amount of study drug in body.

NCT ID: NCT01565681 Completed - Healthy Volunteers Clinical Trials

Study of ASKP1240 After a Single Intravenous Dose at Escalating Dose Levels in Healthy Subjects

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

The objective of this study is to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of ASKP1240 after a single intravenous dose at escalating dose levels in healthy subjects.

NCT ID: NCT01565252 Not yet recruiting - Healthy Volunteers Clinical Trials

Assessment of the Effect of n-3(Omega 3) Fortified Egg in Healthy Subjects

PisNShMiGSL-01
Start date: April 2014
Phase: N/A
Study type: Interventional

Study Rationale: As epidemiological research has shown negative effects of high egg consumption on increased all-cause mortality and diabetes and on diabetes outcomes, and egg modification may modulate their effects on diseases risks, it is important to test the effect of eggs with different composition on markers associated with dyslipidemia, dysglycemia and inflammation. The aim of this study is to assess the effect of n-3PUFA (Omega 3) fortified egg compared to omega-6 Israeli regular egg on metabolic, inflammation and other physiologic parameters.

NCT ID: NCT01565057 Completed - Healthy Volunteers Clinical Trials

Gastric Layering Study

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

This comparative study is designed to compare the gastric layering and rates of emptying and by inference rates of digestion of two food emulsions. Two types of dairy based foods will be used, one which will sediment in the stomach and one that will not. On each of two study days, a total of 9 post drink MRI scans will be taken to assess gastric layering and emptying. Cannulation will allow blood samples to be taken periodically for subsequent analysis for the presence of specific digestion related hormones. A total volume of 36 ml of blood will be removed and volunteers will also be asked to complete a questionnaire at predetermined times to assess feelings of satiation.

NCT ID: NCT01565018 Completed - Healthy Volunteers Clinical Trials

Bioequivalence Study of Rotigotine Transdermal Patch With Two Different Formulations in Healthy Japanese Subjects

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

To investigate and compare the drug amount delivered to the body after each single administration of Rotigotine patch with 2 different formulations in healthy Japanese subjects.