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Healthy Volunteers clinical trials

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NCT ID: NCT01807026 Completed - Healthy Volunteers Clinical Trials

A Study of LY2886721 in Healthy Participants and Participants Diagnosed With Alzheimer's Disease

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

This study is being done for the following reasons: To determine the safety of LY2886721 and any side effects that may be associated with it and to see how much of the study drug is in the blood and the cerebrospinal fluid (CSF) when one dose is given to healthy participants and participants diagnosed with Alzheimer's disease. It will also look at how safe and tolerable the study drug is when given to healthy participants in higher doses. This research study is being conducted in three groups, referred to as Groups (Cohorts) A, B, or C. Group A will enroll participants with Alzheimer's disease while Groups B and C will enroll healthy participants. For Group A or B, participation in this research study could last up to 34 days. For Group C, participation could last up to 60 days.

NCT ID: NCT01806909 Completed - Healthy Volunteer Clinical Trials

Intranasal AD4-H5-VTN as an Adenovirus Vaccine

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

Background: - Adenoviruses are viruses that typically cause symptoms of a cold or eye infection. These viruses are being tested as part of a possible new vaccine. Researchers hope that the adenovirus will help carry the vaccine into the body and cause an immune response. An immune response is the body s release of cells and substances that protect the body from infection. If an adenovirus vaccine can be developed, it might be used as part of a vaccine for malaria or other serious illnesses. Researchers want to test the adenovirus vaccine as a nasal spray in healthy volunteers. The vaccine is called AD4-H5-VTN. - Because the vaccine contains a live adenovirus, there is a possibility that participants can infect other people. Therefore, participants' intimate contacts must join this study. An intimate contact is someone who the participant will kiss on the mouth or have sexual intercourse with during the period of this study. Objectives: - To study the immune response of the AD4-H5-VTN vaccine in healthy volunteers. - To see if the adenovirus in the AD4-H5-VTN vaccine is contagious or spreads to others. Eligibility: - Healthy volunteers between 18 and 49 years of age. - Intimate contacts of healthy volunteers between 18 and 65 years of age. - Participants must not have evidence of previous exposure to adenovirus type 4. Design: - Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. - Participants who will receive the vaccine must be willing to be hospitalized for between 5 and 7 days. They will come to the National Institutes of Health for follow-up visits weekly for the first month, after 8 weeks, in 6 months, and possibly 1 year. They must also avoid all vaccines (including seasonal flu vaccine) and allergy shots for 30 days before and after having the study vaccine. - Participants will enter the hospital for the vaccine study visit. They will receive the vaccine as a nasal spray. Because the vaccine uses a live virus, participants may be contagious for the virus for up to 4 weeks. They will remain in the hospital in respiratory isolation for 7 days, or until they have two negative nasal washes taken 1 day apart. A negative nasal wash means that there is no live virus in the nose. - After leaving the hospital, participants will keep a diary at home for at least 3 weeks. They will record their temperature, any symptoms, or other health changes every day during this time. - Participants should avoid intimate contact with others for 28 days after having the vaccine. Intimate contact includes kissing on the mouth and sexual intercourse. Also, participants should not share kitchen utensils, drinking cups, towels, or hair combs with others. Intimate contacts will also keep track of any illnesses or symptoms they develop during this time. - At the follow-up visits, participants will provide blood and swab samples for study.

NCT ID: NCT01805219 Completed - Healthy Volunteers Clinical Trials

Global Positioning Satellite and Accelerometry to Assess Human Locomotion (ACTI GPS)

ActiGPS
Start date: February 1, 2013
Phase:
Study type: Observational

The aim of the study is to validate the association of the GPS and accelerometer tools in order to assess the humain locomotion during exercises. The hypotheses are: 1. GPS and accelerometer together can assess the human locomotion 2. GPS and accelerometer together can assess the energy expenditure during exercises

NCT ID: NCT01802853 Completed - Healthy Volunteer Clinical Trials

A Bioavailability and Pharmacokinetic Study of Subcutaneous and Intravenous RO6811135 in Healthy Volunteers

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

This open-label, randomized, 2-way crossover study will assess the absolute bioavailability and pharmacokinetics of RO6811135 in healthy male volunteers. Subjects will be randomized to one of the sequences AB or BA to receive single doses of subcutaneous (A) or intravenous (B) RO6811135, with a washout period of at least 7 days between dosing.

NCT ID: NCT01798628 Completed - Healthy Volunteers Clinical Trials

A Study to Determine the Effect of Food on the Pharmacokinetics of Abiraterone Acetate in Healthy Male Patients

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

The purpose of this study is to determine the effect of food on the pharmacokinetics (how the drug concentrations change over time) of abiraterone acetate 1000 mg when administered as a single dose in healthy male volunteers.

NCT ID: NCT01796899 Completed - Healthy Volunteers Clinical Trials

Comparison of Brivaracetam Oral Tablet (10 mg, 50 mg, 75 mg and 100 mg) and Brivaracetam Injection (100 mg) in Healthy Volunteers

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

To investigate the bioavailability/bioequivalence of Brivaracetam oral tablets (10 mg, 50 mg, 75 mg and 100 mg) and Brivaracetam intravenous injection (100 mg) in healthy volunteers.

NCT ID: NCT01796327 Completed - Healthy Volunteers Clinical Trials

A Study To Assess Absorption Of Study Drug Dacomitinib (PF-00299804), Given As An Oral Tablet Compared To An Intravenous Infusion In Healthy Volunteers

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

This study aims to determine the proportion of study drug dacomitinib or PF-00299804, that is taken up from the digestive tract into the body when given as an oral tablet compared with that taken up by an intravenous dose.

NCT ID: NCT01795989 Completed - Healthy Volunteers Clinical Trials

Use of Specially Designed Pediatric MR Coils on Clinical Scanners

Start date: November 18, 2011
Phase:
Study type: Observational

The purpose of this research study is to test the use of new Magnetic Resonance Imaging (MRI) coils. An MRI takes pictures of body parts using a large magnet and a computer. A coil is the part of the MRI system that collects data to make the MR images. The investigators have designed, developed, and built two child-sized coils to use when imaging elbows, wrists, knees, and ankles. These new coils will be better suited to fit infants through teenagers rather than the conventional coils used which were created for adults These MRI coils have not been approved by the US Food and Drug Administration (FDA) and are considered investigational devices.

NCT ID: NCT01786915 Completed - Healthy Volunteers Clinical Trials

Safety and Pharmacokinetic (PK) Study of Oral Bendavia Administered for 7 Days

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

The purpose of this study is to assess the study medication blood levels after administration of a repeat oral capsules (one capsule each day for seven days) of Bendavia at one of two dose levels. The effects of Bendavia on the volunteers will also be assessed.

NCT ID: NCT01786876 Completed - Healthy Volunteers Clinical Trials

Adsorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled SPD557 in Volunteers

Start date: March 7, 2013
Phase: Phase 1
Study type: Interventional

Phase I study to evaluate the excretion of radioactivity, the metabolic profile, pharmacokinetics, safety and tolerability following a single oral administration of [14C] SPD557 in healthy male volunteers aged 18 to 50 years (inclusive).The purpose of this study is to investigate how and how quickly SPD557 or its break down products are excreted by analysing blood, faeces and urine samples collected during the study.