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Healthy Volunteers clinical trials

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NCT ID: NCT02754440 Completed - Healthy Volunteers Clinical Trials

Evaluation of Trima Version 7.0 Platelets in PAS

Start date: April 20, 2016
Phase: N/A
Study type: Interventional

To verify that platelets collected on the Trima Accel system with Version 7.0 software enhancements and stored in platelet additive solution (PAS) meet the FDA requirements for leukoreduction (< 5.0 × 10^6 residual white blood cells [WBC] per transfusable unit).

NCT ID: NCT02750384 Terminated - Healthy Volunteers Clinical Trials

Bioavailability and Effect of Food on DSM265 Granules in Healthy Adult Subjects

Start date: May 2016
Phase: Phase 1
Study type: Interventional

This is a single-dose, fasting and non-fasting, open-label, randomized, three-regimen, parallel group study in 42 subjects

NCT ID: NCT02748694 Completed - Schizophrenia Clinical Trials

Phase 1 TAK-041 First-in-Human Safety, Tolerability, and Pharmacokinetics Study

Start date: May 9, 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of TAK-041: 1. Following oral single and multiple doses in healthy participants. 2. As add-on therapy to antipsychotics in stable schizophrenia participants. 3. To determine the oral bioavailability of the TAK-041 tablet formulation compared to the oral suspension formulation in the fasted state. 4. To assess the effect of food on the PK of TAK-041 in healthy participants.

NCT ID: NCT02747927 Active, not recruiting - Healthy Volunteers Clinical Trials

Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children

TIDES
Start date: September 7, 2016
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the efficacy of 2 doses of Tetravalent Dengue Vaccine Candidate (TDV) in preventing symptomatic dengue fever of any severity and due to any of the four dengue virus serotypes in 4 to 16 year old participants.

NCT ID: NCT02746783 Completed - Healthy Volunteers Clinical Trials

Immunogenicity and Safety of the Seasonal Flu Vaccine in Elderly and in SOT Recipients

Start date: October 2013
Phase: Phase 1/Phase 2
Study type: Interventional

This study will assess the effect of a different dose of the seasonal flu vaccine 2013-2015 on the immune response to improve the investigators understanding of cellular and humoral immune responses induced. The scope of this study is to determine the profile of cellular activation and antibody production in the ageing immune system following flu immunization. This study will enroll 100 male or female subjects ≥65 year old and 90 transplant recipients. These persons will be deemed to be " at risk " in case of influenza infection and should be vaccinated according to Swiss Federal Office of Public Health. A medical doctor from the CHUV will inform the patients about the present study and ask them whether they would be willing to participate in the study. All subjects will be distributed between the two groups according to a computer-generated randomization sequence. The randomization will be done in blocks to ensure balance across groups. The participants and site staff will not be blinded due to the different administration assignments. Group 1 subjects will receive a single dose and group 2 subjects a double dose of MUTAGRIP® manufactured by Sanofi Pasteur containing A/California/7/2009 (H1N1); A/Texas/50/2012 (H3N2); B/Massachusetts/2/2012. Vaccine immunogenicity and safety will be assessed 1, 2, 4 and 24 weeks after vaccination. Study duration per volunteer is 6 months after vaccination.

NCT ID: NCT02746757 Completed - Healthy Volunteers Clinical Trials

Glucagon Like Peptide-1 in Remote Ischemic Conditioning

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

The study was designed to investigate whether glucagon like peptide-1 is a mediator of protection of endothelial function induced by remote ischemic conditioning in ischemia-reperfusion

NCT ID: NCT02744443 Completed - Healthy Volunteers Clinical Trials

Leucine Supplementation in Young Subjects Undergoing Resistance Training

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

Leucine supplementation could be useful to support muscle anabolism. This study aims to investigate the effects of leucine supplementation on muscle mass and muscle strength in young subjects undergoing resistance training.

NCT ID: NCT02742779 Completed - Healthy Volunteer Clinical Trials

A Study to Determine the Safety, Tolerability, and Pharmacokinetics of GDC-0310 in Healthy Volunteers

Start date: September 15, 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of single and multiple orally ascending doses of GDC-0310 administered in healthy participants as 4 parts including Part 1- a single dose (SD) part using a powder-in-capsule (PIC) formulation, Part 2- a multiple dose (MD) part using a PIC formulation, Part 3- a SD part using a solution formulation, and Part 4- a MD part using a solution formulation. Effects of food on pharmacokinetics (PK) will also be explored.

NCT ID: NCT02742766 Completed - Healthy Volunteers Clinical Trials

Safety, Tolerability and Preliminary Pharmacokinetics (PK) and Pharmacodynamics (PD) of Single and Repeat Oral Doses of GSK3008356 in Healthy and Obese Subjects

Start date: March 14, 2016
Phase: Phase 1
Study type: Interventional

This study is a phase I, randomized, placebo-controlled, double-blind (sponsor unblind), three part study. The primary objective of the study is to characterize the safety, and tolerability of GSK3008356 single dose, 14 daily repeat doses in healthy subjects and 28 daily repeat doses in obese subjects. The study has three parts. Part 1, will be a single and multiple-dose, dose-rising study in healthy subjects. Part 2, will be a 14-day, repeat-dose, dose-rising study in healthy subjects, and part 3 will be a 28-day, repeat-dose study in obese subjects. For Parts 1 and 2, data from prior doses cohorts will be available prior to escalation decisions. Data from Parts 1 and 2 will be available prior to initiation of the three parallel cohorts in Part 3. A dose escalation meeting will be held to review these data and document the decision to proceed as planned or make any alterations in dosing, if indicated. Part 1, Part 2 and Part 3 study will have approximately 88, 24 and 30 subjects, respectively.

NCT ID: NCT02736422 Completed - Healthy Volunteers Clinical Trials

Assessment of New Magnetic Resonance Imaging (MRI) Pulse Sequences for Imaging Hyperpolarised Xenon in Lung, Heart and Brain in Volunteers

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

Hyperpolarised gas Magnetic resonance imaging (MRI) (Hyperpolorised 3He and 129Xe MRI) provides novel regional functional images of the lungs. Over the past 14 years researchers at Sheffield Teaching Hospitals NHS Foundation Trust and University of Sheffield have been developing and evaluating different MRI techniques to investigate different aspects of the lung function with both Hyperpolorised 3He and more recently 129Xe gas and have tested these new methods in volunteers with healthy and diseased lungs. This proposed study is to further test the sensitivity of MRI pulse sequences with inhaled 129Xe gas in volunteers. This protocol serves to evaluate the sensitivity of pulse sequences for 129Xe magnetic resonance imaging in the lungs and monitoring the transient changes in vital signs during and following the gas inhalation. This includes evaluation of pulse sequences to image xenon in the heart and brain as well as in the lungs of volunteers.