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Healthy clinical trials

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NCT ID: NCT03670095 Recruiting - Healthy Clinical Trials

Study in Healthy Subjects to Compare Two Tablet Formulations of Memantine (Ebixa®) in Fasted and Fed Conditions

Start date: August 28, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the release of memantine into the bloodstream of two different formulations: one formulation containing lactose and one without lactose.

NCT ID: NCT03670082 Recruiting - Healthy Clinical Trials

Study With Lu AF35700 in Healthy Men and Women in Fasting and Fed State

Start date: September 5, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the extent to which Lu AF35700 enters the bloodstream following pill intake and the influence of food on the uptake in healthy men and women

NCT ID: NCT03668314 Not yet recruiting - Healthy Clinical Trials

Single and Multiple Ascending Dose and Food Effect PK Study in Healthy Adult and Elderly Subjects

Start date: October 10, 2018
Phase: Phase 1
Study type: Interventional

A three (3) part study to evaluate the safety, tolerability and PK of RDN-929

NCT ID: NCT03665844 Recruiting - Healthy Clinical Trials

Smart Sleep In-home Validation Extension Study

Start date: August 14, 2018
Phase: N/A
Study type: Interventional

This study is a nonrandomized, unblinded, uncontrolled case series clinical trial validating the SmartSleep product, including SleepMapper app in the home setting. It is intended to provide data related to product use and cognitive testing incorporating a longer baseline period for comparison purposes. It will include adults (21-50 yr. old) who are working full time and report shortened sleep due to lifestyle. For the purposes of this study, shortened sleep is defined as sleeping at least 5 hrs. of sleep per night, and sleeping less than or equal to 7 hrs. at least 3 nights per week. Participants also increase their sleep duration by ≥ 1 hour on the weekends. In addition, participants report a sleep latency ≤ 30 minutes less than or equal to 3 nights per week. Participants are generally healthy individuals who have not been diagnosed with any sleep-related medical conditions. In addition, participants diagnosed with major organ system diseases or requiring oxygen therapy are excluded from participation. Up to 75 individuals will be consented in order to complete a total of 50 participants using a nonrandomized design. The study involves an initial screening visit followed by home use of the SmartSleep device with SleepMapper app. The home use will include an initial week of baseline use followed by 3 weeks of use with boost on. Study staff will contact participants after the first week of use as a reminder. Participants will be asked to complete a battery of cognitive tests upon wake up each morning. Participants will be asked to complete a question twice daily during the home use period. Additional phone calls may occur on an as needed basis if issues arise. The final visit will be an in facility visit in which all study equipment will be returned. The anticipated study duration will be up to 6 weeks (including the 4 weeks of use period).

NCT ID: NCT03664570 Not yet recruiting - Healthy Clinical Trials

Enteral Nutrition Infusion Rate and Gastric Function

ANTERO-3
Start date: October 1, 2018
Phase: N/A
Study type: Interventional

A complex neurohumoral feedback mechanism regulates gastric emptying of enteral nutrition through changes in gastric motility. In this investigation, we aim to investigate the impact of different infusion rates of enteral nutrition on gastric motility, gastric emptying rate, epigastric symptoms and satiation. Additionally, magnetic resonance imaging will be used to validate an extended 13C-octanoate breath test for gastric emptying of a liquid test meal that is infused over 2 hours. Furthermore, the reliability of a manual position check of the VIPUN Balloon catheter will be confirmed with radiographic imaging. Finally, the data will be used for the data driven optimization of the VIPUN MI algorithm.

NCT ID: NCT03664544 Not yet recruiting - Healthy Clinical Trials

PK Study in Subjects With Severe Hepatic Impairment

MCI-186-E05 HP
Start date: October 2018
Phase: Phase 1
Study type: Interventional

This is an open-label, single-dose study in male and female subjects with severe hepatic impairment and in male and female subjects with normal hepatic function.

NCT ID: NCT03664453 Not yet recruiting - Healthy Clinical Trials

A Pharmacokinetic Study of Omaveloxolone in Healthy Volunteers

Start date: October 2018
Phase: Phase 1
Study type: Interventional

This study will determine the effect of food on the pharmacokinetics of omaveloxolone (150 mg) in healthy adult subjects and will assess the safety, tolerability, and dose proportionality of 50 mg, 100 mg, and 150 mg omaveloxolone in healthy adult subjects. The study will be conducted in two parts, conducted simultaneously. Part 1 will assess the food effect, while Part 2 will assess dose proportionality.

NCT ID: NCT03664011 Recruiting - Healthy Clinical Trials

A Study in Healthy Men to Test How BI 730357 is Processed by the Body

Start date: September 10, 2018
Phase: Phase 1
Study type: Interventional

The main objectives of the study are as follows: - To assess the mass balance recovery of [14C]-radioactivity in urine and faeces after a single oral dose of 50 mg BI 730357 BS (C-14) in healthy male subjects - To provide plasma, urine, and faecal samples for metabolite profiling and structural identification

NCT ID: NCT03662737 Not yet recruiting - Healthy Clinical Trials

VRT as a Biomarker of Cerebellar Dysfunction in Chronic Cannabis Use

Start date: September 2018
Phase:
Study type: Observational

Chronic cannabis consumption has been associated with poor psychosocial functioning that could be associated to cerebellar dysfunction. The cerebellum has a relevant role in adaptation processes and has a high density of cannabinoid 1 receptor (CB1R). Implicit motor learning is a cerebellum dependent function that can be measured with a visuomotor rotation task (VRT). The project aims to identify a sensitive and specific biomarker of cerebellum dysfunction in chronic cannabis users. The investigators would like to demonstrate that the visuomotor rotation paradigm is valid to measure and quantify such a dysfunction. A longitudinal prospective study with a 3 month follow-up is proposed. 3 groups will be included: 1) chronic cannabis users; 2) individuals with an alcohol use disorder; and 3) healthy controls. All groups will be matched by sex and age. Forty individuals will be included in each group. Individuals will be assessed at baseline, at first month and at 3-months of follow-up. Sociodemographic and clinical data will be recorded. Information on cannabis consumption will be registered using an App. Participants will do the visuomotor rotation task and answer three questionnaires: the Intrinsic Motivation Inventory, the Scale for the assessment and rating of ataxia (SARA) and the Harris tests for lateral dominance. The biomarker developed by this project will facilitate the detection of cerebellar alterations in chronic cannabis users, and will permit to quantify and monitor such alteration over time. The team's intention is to patent the proposed model and disseminate it in order to use it in clinical practice at both primary and specialized health centres.

NCT ID: NCT03662100 Recruiting - Healthy Clinical Trials

A Study of Two Formulations of LY3074828 in Healthy Participants

Start date: September 6, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to look at the amount of the study drug, LY3074828, that gets into the blood stream and how long it takes the body to get rid of LY3074828 when given as different formulations. The tolerability of LY3074828 will also be evaluated and information about any side effects experienced will be collected. Screening is required within 28 days prior to the start of the study. For each participant, the study will last about 12 weeks, not including screening.