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Healthy Volunteers clinical trials

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NCT ID: NCT02712190 Recruiting - Healthy Volunteer Clinical Trials

Evaluation of Prolonged Apnea Supported by High Frequency Non-invasive Ventilation.

ANIV
Start date: March 2016
Phase: N/A
Study type: Interventional

The purpose of the study is to assess the efficacy of high-frequency non-invasive ventilation on apnea duration, carbon dioxide clearance and oxygen delivery in healthy subjets and patients with lung disease.

NCT ID: NCT02711423 Completed - Healthy Volunteer Clinical Trials

A Single-Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics (PK) of Gantenerumab Following Subcutaneous (SC) Administration in Healthy Volunteers

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

This two-part study is designed to assess the safety, tolerability, and PK of gantenerumab in healthy volunteers. Part I (dose escalation) will randomly assign participants to receive a single blinded SC dose of gantenerumab or placebo. Part II (PK extension) will randomly assign participants to receive a single open-label SC dose of ganenerumab at different dose levels according to safety assessments from Part I.

NCT ID: NCT02703051 Completed - Healthy Volunteers Clinical Trials

A Study to Evaluate the PK, Safety and Tolerability of GMI-1271 With and Without Filgrastim in Healthy Adult Subjects

Start date: November 2015
Phase: Phase 1
Study type: Interventional

Phase 1, open-label, parallel, active-controlled, multiple IV dose, proof of concept study conducted at one study center in the United States (US).

NCT ID: NCT02701270 Completed - Healthy Volunteers Clinical Trials

Effect of Three Fibres on Glycaemic and Insulinaemic Responses in Healthy Adult Volunteers

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

The purpose of this study is to determine whether DuPont Experimental Dietary Fibre products 1 and 2 are digested using glycaemic and insulinaemic response as markers.

NCT ID: NCT02700776 Terminated - Healthy Volunteers Clinical Trials

1380GCC: Prospective Study of GP-88 Blood Test in Healthy Women With Baseline Gail Model Risk Assessment Undergoing Screening for Breast Cancer

1380GCC
Start date: April 2014
Phase:
Study type: Observational

The purpose of this study is find out if a protein level in the blood (called PC Cell Derived Growth Factor or glycoprotein 88 [GP88]), combined with standard mammography screening, can help detect breast cancer better than mammography screening alone. Earlier research has shown that a certain glycoprotein 88 (GP88) is higher in women with breast cancer. In this study, investigators will measure the level of GP88 in the blood of healthy women who are having mammography screening for breast cancer. The investigator plans to correlate the results of the mammogram with the GP-88 level.

NCT ID: NCT02699710 Completed - Healthy Volunteer Clinical Trials

Effect of Food, Rabeprazole, Methotrexate and Formulation on the Pharmacokinetics (PK) of GDC-0853 and the Effect of GDC-0853 on the PK of Methotrexate in Healthy Subjects

QCL117578
Start date: September 3, 2015
Phase: Phase 1
Study type: Interventional

This study is a Phase I, single center, randomized (Parts 1 and 2 only), open-label, 3 part study. Parts 1 and 2 are 2-way crossover, with 1-fixed sequence, 3-period designs to investigate the effect of formulation, food and rabeprazole on the PK of GDC-0853 in healthy male and female (of non-childbearing potential) participants. Part 3 is a fixed-sequence study with 3 treatments to characterize the steady-state PK of the GDC-0853 tablet; the effect of simultaneous administration of a single dose of methotrexate on the steady-state kinetics of GDC-0853; and the effect of dosing GDC-0853 to steady-state on the single dose PK of methotrexate in healthy male participants.

NCT ID: NCT02699658 Completed - Healthy Volunteers Clinical Trials

Population Pharmacokinetics and Pharmacodynamics Modeling to Optimize Dosage Regimen of Levofloxacin

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

Levofloxacin, a fluoroquinolone antibiotic, is the optical S-(-) isomer of ofloxacin with a broad spectrum of activity. In common with other fluoroquinolones, the main pharmacokinetic/pharmacodynamic (PK/PD) index that correlates with its therapeutic efficacy is the area under the plasma time-concentration curve/the minimum inhibitory concentration ratios. The aims of the study were to: 1. reveal the population pharmacokinetics, and 2. assess the efficacy of various dosage regimens in achieving the probability of target attainment (PTA) and the cumulative fraction of response (CFR) of levofloxacin when oral levofloxacin was prescribed as the switching therapy after intravenous levofloxacin treatment. The study was conducted in 45 healthy volunteers. Each subject received one 500 mg tablet of levofloxacin, after which PK studies were carried out, using a Monte Carlo simulation to determine the PTA. By referral to the EUCAST MIC distributions database, the dosage regimens were predicted to achieve CFR greater than or equal to 90%.

NCT ID: NCT02699372 Completed - Healthy Volunteer Clinical Trials

The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of RO6889450 in Healthy Volunteers

Start date: March 21, 2016
Phase: Phase 1
Study type: Interventional

This randomized, single center, adaptive single ascending dose (Part 1) and multiple ascending dose (Part 2) study is designed to assess the safety, tolerability, pharmacokinetic, and pharmacodynamics following an oral administration of RO6889450 versus placebo in healthy volunteers. The anticipated duration of this study is approximately 18 weeks.

NCT ID: NCT02694484 Completed - Healthy Volunteers Clinical Trials

Search Cytomegalovirus in Healthy Volunteers Stools Samples Selected as Potential Donor for Fecal Microbiota Transplant

TRANSFECMV
Start date: June 2016
Phase: N/A
Study type: Interventional

Fecal microbiota transplantation (FMT) is recommended in the treatment of recurrent Clostridium difficile infection (CDI). The principle is to administer a fecal suspension of a healthy subject (donor) in the digestive tract of a patient with an CDI (receiver). Donors are being clinical and laboratory screening to reduce the likelihood of pathogens transmission (infectious and other). Cytomegalovirus (CMV) is part of the examinations requested by the Agence national de sécurité du médicament et des produits de santé in the context of clinical research. A sero-matching between donor and recipient CMV is requested. This recommendation eliminates many potential donors to a recipient. To date, the frequency detection level of CMV in stool in healthy volunteers with documented positive CMV serology is not known. In addition, CMV transmission risk via the stool is not established. This study aims to determine the detection frequency of CMV in healthy volunteers stool samples selected as potential donors for a FMT and having a positive CMV serology documented

NCT ID: NCT02693613 Completed - Healthy Volunteers Clinical Trials

Pharmacokinetic Study of ASP1517 With Kremezin®

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

The objective of this study is to evaluate the effect of Kremezin® on the pharmacokinetics of single dose of ASP1517 in healthy non-elderly adult male subjects when administered concomitantly or in a time separated manner.