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intranasal oxytocin · 2 trials · 2 indications
Participants will complete a task evaluating emotional expressions. These stimuli are identical to those published previously by Leknes et al., (2012).
Participants will complete a task evaluating faces that morph into different emotional expressions.
Scanning procedures for functional magnetic resonance imaging (fMRI) will include a functional scan during a social cognition task and structural connectivity during rest
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).
Electrocardiogram data will be collected to assess heart rate variability, a measure of cardiac autonomic function.
An eyetracking device will measure eyegaze and pupillometry.
| Arm | Type | Description |
|---|---|---|
| 8IU intranasal oxytocin | ACTIVE_COMPARATOR | 8IU intranasal oxytocin delivered with the OptiNose Breath Powered Bi directional liquid device |
| 24IU intranasal oxytocin | ACTIVE_COMPARATOR | 24IU intranasal oxytocin delivered with the OptiNose Breath Powered Bi directional liquid device |
| Placebo | PLACEBO_COMPARATOR | Placebo delivered with the OptiNose Breath Powered Bi directional liquid device |
| 1 international unit (IU) intravenous oxytocin | ACTIVE_COMPARATOR | Using a double-dummy design participants will be administered 1 IU oxytocin (mixed in 200 ml 0.9% sodium chloride) slow infusion with varying infusion rate over 20 minutes and placebo delivered with the OptiNose Breath Powered Bi-Directional liquid device. Subject to pilot data this may be increased to 2 IU oxytocin (mixed in 200 ml 0.9% sodium chloride) and the infusion time/rate may change to best match the pharmacokinetic profile of intranasally administered oxytocin. |
| Name | Type | Description |
|---|---|---|
| 8IU intranasal oxytocin | DRUG | - |
| 24IU intranasal oxytocin | DRUG | - |
| Placebo | DRUG | - |
| OptiNose Breath Powered Bi | DEVICE | - |
| 24 IU intranasal oxytocin | DRUG | - |
| 1 IU intravenous oxytocin | DRUG | - |
Inclusion Criteria: * Male subjects between the ages of 18 and 35, both inclusive, with a confirmed diagnosis of autism spectrum disorder (ASD) diagnosis. * Subjects must be in good general health, as determined by the investigator. * Subject's pre-study physical examination, vital signs and electr...
Intranasal oxytocin is being investigated for use in Autism Spectrum Disorder and in healthy male adults. It is an investigational small molecule in Phase 1 clinical development for these populations. The drug is administered intranasally and is being studied for its effects in these groups.
Intranasal oxytocin is being developed by OptiNose, Inc., a company traded on the stock exchange under the ticker OPTN. The company is conducting clinical trials to evaluate the drug's effects in healthy adults and in adults with Autism Spectrum Disorder.
Intranasal oxytocin is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, one in healthy male adults and one in male adults with Autism Spectrum Disorder.
Intranasal oxytocin has been studied in two completed Phase 1 clinical trials. NCT01983514 evaluated a single dose in healthy male adults in Norway, enrolling 19 participants. NCT02414503 evaluated a single dose in male adults with Autism Spectrum Disorder in Norway, enrolling 17 participants.
Intranasal oxytocin is a formulation of oxytocin that is administered through the nose using a novel device. It is being studied for its effects when delivered intranasally, as opposed to other routes of administration. The drug is in Phase 1 development by OptiNose, Inc.