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The main objective of the study is to evaluate the acute effects of fasting over inflammatory responses.
The purpose of this study is to investigate safety, tolerability and pharmacokinetics of the drug Lu AF76432 given as single oral ascending doses to healthy young men
The main goal of the study is to confirm that, due to their rich nutritional content in protein, polyunsaturated fatty acids, vitamins and minerals of interest (calcium and magnesium), the regular consumption of the recommended amount of pistachios by adult women will elicit appropriate satiety and compensation in the daily energy intake, and improve diet quality, anthropometry and body composition.
This study examines the impact of routine dinner time versus late dinner time on nocturnal metabolism. Specifically, investigators will examine plasma profiles of free fatty acids, glucose, insulin, triglycerides, and oxidation of dietary fat.
This is a Phase I, single-center, open-label, single-sequence, study evaluating the absorption, metabolism, and excretion of napabucasin in healthy adult male volunteers using a mixture 14C-radiolabeled and unlabeled material.
Previous evidence showed hyperbaric oxygen can enhance aerobic and anaerobic performance during the exposure. The effect of continuous exposure of hyperbaric oxygen on performance was never evaluated.
Current pathophysiological models of schizophrenia focus on disconnectivity of distributed neuronal systems to explain the multitude of psychic symptoms. However, therapeutic strategies targeting this specific pathobiology are lacking. Our recent work provides strong evidence that complex video-game training interventions facilitate fronto-hippocampal structural and functional connectivity within 2 months in healthy subjects. The planned project transfers this knowledge into a training study in schizophrenic patients to counteract disease-related disconnectivity. Underlying mechanisms and behavioral effects are extensively parametrized by resting state functional magnetic resonance imaging (fMRI), diffusion tensor imaging (DTI), spectroscopy and clinical short- and long-term outcome.
This study will evaluate SYNB1618 (investigational product) in healthy volunteers (HV) and subjects diagnosed with phenylketonuria (PKU) for the possible treatment of PKU. Phenylketonuria (PKU) is a rare inherited metabolic disorder that occurs in people who are missing an enzyme that the body needs to use phenylalanine. Eligible subjects will receive investigational product (IP) in the clinic, and will undergo safety monitoring, evaluations and subsequent follow-up after IP administration.
This is an open-label, non-randomized, single dose, pharmacokinetic study in 36 healthy adult male and female volunteers, including 18 smokers and 18 non-smokers. All subjects will be administered a single inhaled dose of Staccato alprazolam 1 mg via hand-held inhaler. Blood samples will be drawn for pharmacokinetic analysis. Eligible subjects are admitted to Phase 1 unit for up to 48 hours. Subjects will receive a post-study safety phone call 14 days(± 2 days) after dosing.
This is an open label, single sequence, crossover study. In Part 1, eligible subjects will participate in 3 treatment periods, in which they will receive the following treatments in turn: 1) In Period 1, a single 350 mg dose of relacorilant administered alone, 2) In Period 2, once daily 200 mg doses of itraconazole administered for 3 days; 3) In Period 3, single 350-mg dose of relacorilant administered with a concomitant 200 mg dose of itraconazole and continued once daily 200 mg doses of itraconazole for three additional days. If Part 2 is conducted, eligible subjects will participate in 3 treatment periods, in which they will receive the following treatments in turn: 1) In Period A, 14 days of oral dosing with "higher dose" relacorilant alone; 2) In Period B, 14 days of oral dosing with "lower dose" relacorilant alone; 3) In Period C, 14 days of oral dosing with "lower dose" relacorilant in combination with itraconazole.