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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.
The aim of the present study is to increase the general understanding of lung PK of selected compounds by sampling epithelial lining fluid ELF and lung tissue.
The primary objectives of this study are to: - Evaluate the ability of the older adults to understand the biological processes underneath a pain experience. - Evaluate their ability to modify their behaviors and beliefs about pain and health.
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.
The present study has been designed to evaluate the effect of three doses of trazodone (20, 60 and 140 mg), in comparison to placebo, on the QT/QTc interval of healthy volunteers. Trazodone oral drops 6% formulation has been selected in order to evaluate the three doses using the same formulation, because the lowest available strength for the tablet formulations is 50 mg. According to the E14 guideline on the evaluation of QT/QTc interval prolongation and proarrhythmic potential of antiarrhytmic drugs, a negative control (placebo) and a positive control (moxifloxacin) will also be assessed.
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.
The sponsor wants to investigate how well the test medicine is taken up by the body when given alongside two other already approved medicines. This kind of study is known as a drug-drug interaction study. In this case the other medicines are itraconazole and voriconazole. The sponsor will also look at the safety and tolerability of the test medicine when taken alone, and when taken with the approved medicines.
single-dose, comparative bioavailability study of two formulations of ursodiol 500mg tablets under fed conditions