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Healthy Volunteers clinical trials

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NCT ID: NCT02999191 Completed - Healthy Volunteers Clinical Trials

Relative Bioavailability of BI 1467335 Tablet and Oral Solution, and Food Effect on Tablet in Healthy Male Subjects

Start date: January 10, 2017
Phase: Phase 1
Study type: Interventional

The primary objective of this trial is to investigate the relative bioavailability of BI 1467335, given as film-coated tablet compared to BI 1467335, given as oral solution. This assessment will be performed under fasted conditions. Furthermore, the effect of food on relative bioavailability of the tablet formulation of BI 1467335 will be investigated.

NCT ID: NCT02998190 Completed - Healthy Volunteers Clinical Trials

First-in-Human Single and Multiple Dose of EB8018

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

The purpose of this study is to determine the safety profile of single and multiple doses of EB8018 in healthy male subjects, to determine the pharmacokinetic profile of single and multiple doses of EB8018 in healthy male subjects and to assess preliminary effects of EB8018 on the healthy male gut microbiome.

NCT ID: NCT02996084 Completed - Healthy Volunteer Clinical Trials

MS PATHS Normative Sub-Study

Start date: December 12, 2017
Phase:
Study type: Observational

The primary objective of this study is to determine the normative range of brain volume and brain volume change in healthy control (HC) participants whose age, race, and gender distribution is approximately matched to the age, race, and gender distribution of patients with Multiple Sclerosis (MS) enrolled in Study 888MS001. The secondary objective is to use the results of the primary endpoint to ensure consistency of brain volume measurements across MS PATHS centers.

NCT ID: NCT02996019 Completed - Healthy Volunteers Clinical Trials

A Study to Compare Pharmacokinetics (PK) of Etrolizumab Administered Subcutaneously by a Prefilled Syringe With Needle Safety Device (PFS-NSD) or an Auto-injector (AI)

Start date: December 7, 2016
Phase: Phase 1
Study type: Interventional

This is a randomized, 2-part, 2-arm, open-label, parallel-group, multi-center study to compare the PK of etrolizumab administered subcutaneously by an AI (test device) or a PFS-NSD (reference device) in healthy participants. The study will comprise a pilot cohort (Part 1) to estimate the geometric mean ratio (GMR) and variability of the maximum observed concentration (Cmax) and area under the concentration-time curve (AUC) to confirm or determine the sample size for the pivotal cohort (Part 2). The pivotal cohort will demonstrate exposure comparability of Cmax, AUC from Hour 0 to the last measurable concentration (AUClast), and AUC from Hour 0 to extrapolated infinite time (AUC0-inf), values for a single dose of etrolizumab administered subcutaneously either by the AI or the PFS-NSD.

NCT ID: NCT02995590 Recruiting - Healthy Volunteers Clinical Trials

Assessing Deformable Image Registration in the Lung Using Hyperpolarized-gas MRI

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

Recently, the investigators have demonstrated a novel hyperpolarized helium tagging Magnetic Resonance Image (MRI) technique that is capable of directly, in vivo, and non-invasively measuring physiological lung deformation on a regional basis. This unique imaging technique holds great promise for assessing, validating, and improving the use of Deformable image Registration (DIR) algorithms in the lung. Our long term aim is to apply hyperpolarized gas tagging MRI to study lung biomechanics, develop more physiologically sound DIR algorithms for the lungs, and eventually improve radiotherapy of lung cancer. The overall aim of this application is to optimize the hyperpolarized helium tagging MRI technology and establish its usefulness for DIR assessment. Our first objective is to develop and optimize a methodology based on 3 Dimensional (3D) hyperpolarized helium tagging MRI of healthy subjects, for directly measuring lung deformation between inhalation and exhalation. Our second objective is to develop physiologically sound digital thorax phantoms based on helium-3 tagging MRI of healthy subjects and demonstrate their use for DIR assessment in the lung. These phantoms will be used to evaluate a range different DIR algorithms, by comparing the errors between the DIR-derived deformation vector fields and the ground truth represented in the digital phantom. Successful completion of these aims will yield a novel methodology for DIR assessment in the lung for radiotherapy.

NCT ID: NCT02994381 Completed - Healthy Volunteers Clinical Trials

A Single Dose Oral Excretion Balance Study of [14C]-RPC1063 in Healthy Male Adults

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

This will be an open-label, non-randomized, single oral dose study in healthy male subjects. All subjects will receive a single oral dose of 10 mL of [14C]-RPC1063 Solution (0.1 mg/mL), containing NMT 1.3 MBq (37 μCi) 14C.

NCT ID: NCT02991508 Completed - Healthy Volunteers Clinical Trials

Adrecizumab Phase 1 Trial

Start date: May 23, 2016
Phase: Phase 1
Study type: Interventional

This is the first clinical trial with ADRECIZUMAB. The purpose of this clinical trial to identify safety and tolerability of different doses of ADRECIZUMAB in healthy volunteers.

NCT ID: NCT02984150 Completed - Healthy Volunteers Clinical Trials

Effect of Intragastric Administration of Fatty Acids on Generalized Reward Sensitivity

Start date: November 2014
Phase: N/A
Study type: Interventional

This study aim to investigate the influence of intragastrically infused fatty acid on the generalization of responses to reward within the food domain and between financial and sexual domains.

NCT ID: NCT02982616 Completed - Healthy Volunteers Clinical Trials

Influence of Intragastric Fatty Acid Infusion on Behavioral Responses to Positive Emotion Induction in Healthy Subjects

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

The purpose of this study is to test whether intragastrically infused fatty acid will interact with positive emotion induction and if this effect is mediated by gut hormones.

NCT ID: NCT02982551 Withdrawn - Healthy Volunteers Clinical Trials

Insulin Modulation of fMRI Connectivity in Healthy Adults

Start date: January 1, 2016
Phase: Early Phase 1
Study type: Interventional

This study evaluates the effects of changing insulin levels on brain activity. Participants will complete functional magnetic resonance imaging (fMRI) scans during fasting conditions, then during an insulin infusion.