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Healthy Volunteers clinical trials

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NCT ID: NCT02910479 Completed - Healthy Volunteers Clinical Trials

Study Evaluating the Relevance and Reliability of Gastrointestinal Temperature Measurements From a New Device (E-celsius)

e-TEMP
Start date: November 2015
Phase: Phase 1
Study type: Interventional

E-Celsius device used for measuring the gastrointestinal temperature is composed of an ingestible capsule measuring the temperature as well as a transportable module receiving data from the capsule. This device allows to measure the body temperature (± 0.2 ° C) during transit of the pill in the digestive tract to a maximum sampling frequency of 30 seconds. The main risks related to such devices are related to biocompatibility (in materials used for the capsule shell, or level of contamination of the gastrointestinal environment due to a defect in the plastic envelope the pill or a lack of hygiene, previously tested in clinical trials; see section 10.2). It will compare conventional methods of estimating the central temperature continuously with gastrointestinal data obtained from the e-Celsius device. The main objective of the research is to validate the extent of gastrointestinal temperature obtained from the device under test consists of an ingestible electronic capsule and a data reception monitor. Secondary objectives will be pursued: - Assess the effects of ingestion of cold drinks on temperature readings taken via e-device Celsius, esophageal probe and a rectal probe. - Explore the thermal homogeneity of the digestive tract. - Evaluate the internal memory of the capsule and its data forwarding capacity. This protocol will also measure the reliability of the measurement system while comparing it to the standards used by health staff today.

NCT ID: NCT02906813 Completed - Healthy Volunteers Clinical Trials

A Study to Determine the Bioavailability and Food Effect of a Single TAK-935 Dose in Healthy Participants

Start date: September 12, 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the relative bioavailability (BA) of 300 milligram (mg) TAK-935 tablets compared to 300 mg of TAK-935 solution and to determine the effect of food on the BA of TAK-935 300 mg tablets in healthy adult participants.

NCT ID: NCT02906176 Completed - Healthy Volunteers Clinical Trials

Influence of SLCO2B1 Polymorphism on the PK of Voriconazole in CYP2C19 PM

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

A clinical trail to investigate the influence of SLCO2B1 polymorphism on the pharmacokinetic characteristics of voriconazole in CYP2C19 poor metabolizers

NCT ID: NCT02904616 Completed - Healthy Volunteers Clinical Trials

Validation of a Medical Device, a Mobile Spectrofluorimeter, Measuring Skin Autofluorescence in Healthy Volunteers.

PHOTOFLUO
Start date: January 26, 2015
Phase: N/A
Study type: Interventional

The Institut has developed a spectrofluorimeter for the registration and monitoring of skin autofluorescence. This Spectrofluorometer must be initially validated in healthy volunteers. In the long term, it will be used clinically to measure residual photosensitivity of patients who received a photosensitizer in photodynamic therapy.

NCT ID: NCT02900339 Completed - Healthy Volunteers Clinical Trials

Magnetic Resonance Imaging (MRI) Sequences Optimization in Healthy Subjects

OSS-IRM
Start date: April 18, 2013
Phase: N/A
Study type: Interventional

Magnetic resonance imaging (MRI) is a noninvasive and non-ionizing (no use of X-rays) imaging modality. Today it is considered an anatomical and functional exploration reference technique. Since its inception around 1985, this technology is constantly evolving. Many advances in MRI require constant adaptations of radiological practices. The morphological image is now associated with functional and parametric information (infusion, diffusion spectroscopy, etc ...). In parallel, work combining acquisition and post-processing of data also open new applications (tractography, functional MRI, etc ....). Thus, more and more procedures are necessary to "integrate" these techniques for the diagnosis and adapt to new demands of clinicians. The type of sequence and its associated parameters allow to directly influence the contrast of images, to characterize tissue compared to another and, ultimately, to highlight morphological or functional abnormality. Image quality can be optimized on each MRI, depending on the time available for the acquisition on the one hand, and on the desired resolution and contrast, on the other hand. For each sequence, it is therefore necessary to find a compromise that will optimize the diagnostic quality of the examination. This optimization requires a phase focusing on healthy volunteers. It is therefore important that researchers and physicists could design on healthy volunteers, the best settings of all parameters for an image or spectrum. Indeed, it is always necessary to properly optimize every parameter choices before beginning a study of a cohort of patients. In this context, the main objective of this study is to optimize sequences and imaging protocols to evaluate and validate the choice of parameters in healthy volunteers.

NCT ID: NCT02897674 Completed - Healthy Volunteers Clinical Trials

Effect of Palm Olein Intake on Lipid Profile and Fat Deposition

PalmOil
Start date: February 2016
Phase: N/A
Study type: Interventional

Aims: To investigate whether diet with realistic doses on palm oil will have an effect on lipid profile and fat deposition in healthy volunteers.

NCT ID: NCT02894541 Completed - Healthy Volunteers Clinical Trials

Study to Investigate the Effects of Food on the Pharmacokinetics/Pharmacodynamics of CKD-519

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

The purpose of this study is to investigate the effects of food on the pharmacokinetics/pharmacodynamics of CKD-519.

NCT ID: NCT02882009 Completed - Healthy Volunteer Clinical Trials

A Study to Assess the Impact of Speed and Site of Subcutaneous Injection on Pain, Tolerability, Safety, and Pharmacokinetics of Gantenerumab in Healthy Participants

Start date: August 31, 2016
Phase: Phase 1
Study type: Interventional

The purpose of this randomized, open-label, parallel-group, placebo-controlled study is to assess pain following subcutaneous (SC) administration of gantenerumab as a high-concentration liquid formulation (HCLF) at different injection speeds. The total duration of the study for each healthy participant will be up to approximately 21 weeks.

NCT ID: NCT02881853 Completed - Healthy Volunteers Clinical Trials

Safety, Tolerability, and Bioavailability of Subcutaneously Administered XmAb®7195

Start date: August 17, 2016
Phase: Phase 1
Study type: Interventional

This is a Phase 1b, combined multiple dose subcutaneous (SC) bioavailability (BA) and multiple ascending dose (MAD) study evaluating safety, tolerability and BA of SC XmAb7195 in healthy subjects and in subjects with atopic disease.

NCT ID: NCT02879877 Completed - Healthy Volunteers Clinical Trials

A First-In-Human Study With a Single Ascending Dose of UCB7858 in Healthy Volunteers

Start date: July 11, 2016
Phase: Phase 1
Study type: Interventional

This study is designed to evaluate the safety and tolerability of UCB7858 when given as single ascending doses administered by intravenous or subcutaneous infusion in healthy subjects.