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Healthy Subjects clinical trials

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NCT ID: NCT04252495 Completed - Healthy Subjects Clinical Trials

The Effect of Hepatic Impairment on Aprocitentan Pharmacokinetics

Start date: June 26, 2020
Phase: Phase 1
Study type: Interventional

This is a prospective, open-label, single-dose, Phase 1 study, to assess the effect of moderate hepatic impairment due to liver cirrhosis on the pharmacokinetics of aprocitentan (ACT-132577).

NCT ID: NCT04245059 Enrolling by invitation - Healthy Subjects Clinical Trials

Safety Study Based on Transcranial Electrical Stimulation in Chile: a Case Series Study

Start date: December 1, 2019
Phase: N/A
Study type: Interventional

Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulation technique that delivers low-intensity, direct current to cortical areas facilitating or inhibiting spontaneous neuronal activity. It has been used to improve cognitive functions such as memory, language, and attention. Research has also shown that tDCS on motor cortex can improve motor performance. TDCS secondary effects have been measured in several studies. The most frequent secondary effects described in literature are a mild tingling sensation, moderate fatigue, itching sensation, slight burning and mild pain sensation under the electrodes during the stimulation. The present study is focused in evaluate the safety of a transcranial direct current stimulation (TDCS) service by measuring secondary effects incidence in a group of healthy subjects. In addition, manual dexterity and upper limb strength will be measure to identify improvement in motor performance after intervention.

NCT ID: NCT04241393 Completed - Healthy Subjects Clinical Trials

An Open-label Trial to Evaluate Mass Balance of Tavapadon at Steady State in Healthy Subjects

Start date: February 4, 2020
Phase: Phase 1
Study type: Interventional

The purpose of this trial is to determine the absorption, metabolism, and excretion (AME) of [14C] tavapadon.

NCT ID: NCT04206540 Recruiting - Healthy Subjects Clinical Trials

Effect of Stimulation on the Vagus Nerve

Start date: July 22, 2019
Phase: N/A
Study type: Interventional

The vagus nerve is a largely-internal nerve that controls many bodily functions, including stomach function. Investigators hope that electrically stimulating the nerve around the external ear will also stimulate the internal vagus nerve. If it does, then investigators hope that this will help the treatment of patients with nausea and vomiting and disordered stomach function. Investigators also hope to be able to measure the activity of the vagus nerve when it is stimulated in other ways. This could help investigators learn more about studying this nerve in the future.

NCT ID: NCT04205045 Completed - Healthy Subjects Clinical Trials

Identification of Physiological Biomarkers of Gastro-intestinal Discomforts Induced by Milk Consumption

MIDI
Start date: October 1, 2018
Phase:
Study type: Observational

This study aims to explore digestibility of lactose and milk proteins, gut permeability, microbiota composition and psychological wellbeing status in healthy subjects who are non-habitual milk consumers due to milk-related gastro-intestinal discomfort in comparison with healthy and habitual milk consumers.

NCT ID: NCT04189484 Completed - Healthy Subjects Clinical Trials

Pharmacodynamic Biomarkers to Support Biosimilar Development: PCSK9 Inhibitors

Start date: January 7, 2020
Phase: Phase 1
Study type: Interventional

This study is designed to assess pharmacokinetics and pharmacodynamics of evolocumab and alirocumab across an appropriate dose range to inform clinical trial operating characteristics for future clinical pharmacology pharmacodynamics similarity studies. This is a randomized, placebo-controlled, single-dose, parallel arm study in 72 healthy subjects assigned to one of four dose groups (low, intermediate low, intermediate high, and high) of each drug (evolocumab and alirocumab ) or placebo.

NCT ID: NCT04188626 Completed - Healthy Subjects Clinical Trials

Identification of Biomarkers to Predict Driver Take-over Control Quality

ANTIDOTE
Start date: December 9, 2019
Phase: N/A
Study type: Interventional

At level 3 conditionally automated, the vehicle ensures driving and the driver disengages from driving to perform another activity independent of driving (ex: read a book, play on his phone ....). However, drivers are expected to be available to take over control for the case of system failure or limitation. This take-over control must take place in a limited time, very short, of the order of a few seconds. To take-over control of the vehicle quickly and efficiently, the driver must be, at the time of take-over, vigilant, efficient, and attentive to the environment and focused on the take-over of manual driving. Predicting the driver's reengagement capabilities to ensure that the driver will be able to take-over control of the vehicle is crucial at level 3 of autonomous driving. The objective of ANTIDOTE is to determine physiological and behavioural parameters capable of predicting the take-over quality in level 3 conditionally automated vehicles in a simulated highway driving situation in healthy drivers or drivers with attention disorders.

NCT ID: NCT04183491 Completed - Healthy Subjects Clinical Trials

Pharmacodynamic Biomarkers to Support Biosimilar Development: Interferon Beta-1A Products

Start date: February 28, 2020
Phase: Phase 1
Study type: Interventional

This study is designed to assess pharmacokinetics and pharmacodynamics of interferon beta-1a and peginterferon beta-1a across an appropriate dose range to inform clinical trial operating characteristics for future clinical pharmacology pharmacodynamics similarity studies. This is a randomized, placebo-controlled, single-dose, parallel arm study in 84 healthy subjects assigned to one of three dose groups (low, intermediate, and high) of each drug (interferon beta-1a and peginterferon beta-1a) or placebo.

NCT ID: NCT04183192 Completed - Healthy Subjects Clinical Trials

Pharmacodynamic Biomarkers to Support Biosimilar Development: Interleukin-5 Antagonists

Start date: February 17, 2020
Phase: Phase 1
Study type: Interventional

This study is designed to assess pharmacokinetics and pharmacodynamics of mepolizumab and reslizumab across an appropriate dose range to inform clinical trial operating characteristics for future clinical pharmacology pharmacodynamics similarity studies. This is a randomized, placebo-controlled, single-dose, parallel arm study in 72 healthy subjects assigned to one of four dose groups (low, intermediate low, intermediate high, and high) of each drug (mepolizumab or reslizumab) or placebo.

NCT ID: NCT04164719 Completed - Healthy Subjects Clinical Trials

Dose-Proportionality and Food Effect Study of TNX-102 SL

Start date: October 14, 2019
Phase: Phase 1
Study type: Interventional

This will be a single center, single-dose, randomized, open-label, 3-period, crossover, dose-proportionality and food-effect study.