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The main objectives of this first-into-man study were to investigate the safety, tolerability and the pharmacokinetic profile of single oral doses of ACT-541468 in healthy male adults. Pharmacodynamic effects (through a battery of Central Nervous System tests) were also assessed.
The study consisted of ascending dose groups; each dose group was investigated in a new group of 8 healthy male subjects (6 on active drug and 2 on placebo). In addition, the study included a biocomparison part (dose group 2), an absolute bioavailability part (dose group 4), and a mass balance / metabolism part (dose group 3).
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)
ACT-541468 (Formulation A), ACT-541468 (Formulation B), Placebo (Formulation A), Placebo (Formulation B), 14C-labeled ACT-541468, Placebo tracer
Published on BioPortfolio: 2016-09-29T23:08:21-0400
The purpose of this study is to evaluate in a double-blinded fashion the taste and overall acceptability profile of different ALS-008176 oral liquid formulations as compared to the referen...
The primary objective of this study is to assess the effect of ACT-541468 on a measure of sleep maintenance (Wake after Sleep Onset or WASO) by polysomnography in subjects with insomnia di...
The main objectives of this phase 1 trial are to evaluate the effect of food on the pharmacokinetics or PK (i.e. how long and how much a compound is present in the blood) of ACT-541468 and...
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Solithromycin is a fluoro-ketolide (a fourth-generation macrolide) antibiotic that has been undergoing clinical trials for the treatment of community acquired bacterial pneumonia. In this study, devel...
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A type of viscous polysaccharide that is secreted from PLANTS. It has natural properties that are useful in the formulation of ADHESIVES.
A method of treating an ALLERGY by administering ALLERGENS, in liquid formulation or tablets, to the ORAL MUCOSA under the tongue.
Disorders in which phagocytic cells cannot kill ingested bacteria; characterized by frequent recurring infection with formulation of granulomas.
A field of biological research combining engineering in the formulation, design, and building (synthesis) of novel biological structures, functions, and systems.
Insulin formulation containing substance which delays or retards time period of the absorption of insulin.
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...