Healthy Male Adults
Conditions
Keywords
oxytocin, fMRI, social cognition, heart rate variability, pupillometry, eye tracking
Brief summary
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.
Interventions
Sponsors
University of Oslo
OptiNose AS
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aim 1d: Eyetracking | 20 minutes after oxytocin placebo administration | An eyetracking device will measure eyegaze and pupillometry. |
| Aim 1a: Brain activity | 30 minutes after oxytocin/placebo administration | Scanning procedures for functional magnetic resonance imaging (fMRI) will include a functional scan during a social cognition task and structural connectivity during rest |
| Aim 1b: Performance on a social cognition test | 45 mins after oxytocin/placebo administration | Participants will complete a task evaluating emotional expressions (either happy expressions, fear expressions or neutral expressions). These stimuli are identical to those published previously by Leknes et al., (2012). |
| Aim 1c: Heart rate variability | 20 minutes after oxytocin placebo administration | Electrocardiogram data will be collected to assess heart rate variability, a measure of cardiac autonomic function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic (PK) profile of oxytocin | 5 minutes prior to oxytocin/placebo administration | Blood will be collected to assess levels of oxytocin present in peripheral blood to measure PK profile of 8 and 24 international units (IU) oxytocin delivered with OptiNose device and of 1 IU oxytocin after slow intravenous (IV) infusion. |
| Plasma concentration of cortisol | 20 minutes before fMRI procedure | Blood will be drawn at various intervals for the pharmacokinetic analysis of plasma cortisol. |
| Oxytocin levels in saliva | 20 prior to fMRI procedure | Saliva will be collected for pharmacokinetic analysis of oxytocin and cortisol in saliva. |
| Cortisol levels in saliva | 20 minutes prior to fMRI procedure | Saliva will be collected for pharmacokinetic analysis of oxytocin and cortisol in saliva. |
Countries
Norway
Outcome results
None listed