Effects of Intranasal Administration of a Single Dose of Oxytocin Using a Novel Device in Healthy Adults
Effects of Intranasal Administration of a Single Dose of Oxytocin Using a Novel Device in Healthy Adults
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.
Inclusion Criteria:

 -  Healthy, male subjects aged 18 to 35 years inclusive.

 -  Subjects must be in good general health, as determined by the investigator.

 -  Subject's pre-study physical examination, vital signs and electrocardiogram (ECG) are
 normal or do not show any clinically significant abnormalities as determined by the
 investigator. Vital signs must not have any clinically significant deviations outside
 of the following ranges when measured sitting after 5 minutes rest:

 1. Heart rate: 40 to 90 beats per minute

 2. Systolic blood pressure (BP): 90 to 140 mmHg

 3. Diastolic BP: 50 to 90 mmHg

 4. Oral temperature: 36.0 to 37.5°C

 5. Respiratory rate: 12 - 18 breaths per minute

 -  Body Mass Index (BMI) of 18.5 - 29.9 kg/m2 (both inclusive)

 -  Subjects must be able to communicate well with the Investigator, to understand and
 comply with the requirements of the study, and understand and sign the written
 informed consent

 -  Provision of written informed consent.

 Exclusion Criteria:

 An ear, nose and throat (ENT) specialist will inspect the noses of all individuals who
 enter the study.

 In order to participate in the study subjects must not meet any of the following exclusion
 criteria;

 -  Individuals showing major septal deviation or a significantly altered nasal
 epithelium.

 -  Participants with evidence of previous nasal disease, surgery, and dependence on
 inhaled drugs.

 -  Individuals with current significant nasal congestion due to common colds.

 -  Subjects with a clinically relevant history of significant hepatic, renal, endocrine,
 cardiac, nervous, psychiatric, gastrointestinal, pulmonary, haematological or
 metabolic disorder.

 -  Subjects with current or history of, any clinically significant disease or condition
 known to interfere with the absorption, distribution, metabolism or excretion of
 drugs.

 -  Subject is taking any regular prescribed or over-the-counter (OTC) medications
 including vitamin supplements and herbal remedies. There must be at least 14 days
 between stopping these products and the first dose of study medication).

 -  Systemic illness requiring treatment within 2 weeks prior to Study Day 1.

 -  History of significant drug or alcohol abuse (as per a self-report measure /
 instrument; World Health Organisation criteria/Alcohol use disorders identification
 test/Drug use disorders identification test). Subjects with a positive screen for
 alcohol or drugs of abuse at screening/admission will be excluded from participation
 in the study.

 -  Self-reported significant psychiatric conditions.

 -  Any abnormal laboratory values outside normal range, and which is clinically
 significant as deemed by investigator.

 -  Full scale intelligence quotient (IQ) < 75 (due to the prerequisite ability to
 complete self report measures).

 -  Known allergic reactions or hypersensitivity to any component of the study medication
 in the nasal spray, such as E216, E218 and chlorobutanol hemihydrate.

 -  Participation in any (other) clinical trial with an investigational medicinal product
 or medical device within 3 months prior to randomisation.

 -  Current evidence of any mental or physical disorder or collaboration attitude which,
 in the judgment of the investigator makes the subject unsuitable for enrolment, and/or
 may interfere with the study evaluations or affect subject's safety.

 -  Subjects with any metal implants.

 -  Subjects with claustrophobia.

 -  Other unspecified reasons that, in the opinion of the Investigator or the sponsor make
 the subject unsuitable for enrolment.

 -  Subjects with female partners of child-bearing potential must use an adequate form of
 contraception prior to entry into the study until three months following the
 post-study medical visit. Subjects must not have a partner who is either pregnant or
 breastfeeding for the duration of the study. Adequate contraception is defined as the
 usage by the female partner of any form of hormonal contraception or intra-uterine
 device (which should be established prior to the start of the study) plus usage by one
 of the partners of an additional spermicide- containing barrier method of
 contraception.