Healthy Male Adults Clinical Trial
Official title:
Intranasal (Optinose Bidirectional Nose-to-brain Device) Versus Intravenous Slow Infusion of Oxytocin - a Randomized, Placebo- Controlled Double-blind, Double-dummy 4-period Cross-over Study in Healthy Adult Volunteers Evaluating Brain Functional Magnetic Resonance Imaging Changes, Cognitive Response, Heart Rate Variability, Plasma Pharmacokinetics and Saliva Concentration After Single-dose Oxytocin 8 or 24 International Units (IU) Intranasally or 1 IU as Slow Intravenous Infusion
Oxytocin (OT) is a small, naturally occurring peptide currently in clinical use to stimulate
lactation in breastfeeding women. The intranasal administration of OT has recently attracted
attention as a potential novel treatment in several psychiatric disorders including autism.
However, given the anatomy of the nasal cavity, the current design of nasal sprays would be
expected to provide an inadequate delivery of medication to the areas of the nasal cavity
where direct transport into the brain via the olfactory nerve could potentially occur.
OptiNose has developed an intranasal delivery device that provides improved reproducibility
of nasal delivery, improved deposition to the upper posterior regions of the nasal cavity
where the olfactory nerve innervates the nasal cavity.
The primary objective of this study is to identify any differences between single dose 8 or
24 international units (IU) oxytocin delivered intranasally with the optimised OptiNose
device and 1 IU oxytocin administered as slow intravenous infusion in healthy volunteers.
This will be measured in terms of brain activity as measured with functional magnetic
resonance imaging (fMRI), performance on cognitive tests, and physiological markers.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
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