Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01983514 | Effects of Intranasal Administration of a Single Dose of Oxytocin Using a Novel Device in Healthy Adults | PHASE1 | COMPLETED | 19 | — | — | Oct 1, 2013 | Feb 1, 2014 | Apr 23, 2014 | 1 | Norway |
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 |
|---|---|---|
| 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. |
| Placebo | PLACEBO_COMPARATOR | Using a double-dummy design participants will be administered Placebo delivered with the OptiNose Breath Powered Bi-Directional liquid device and placebo delivered intravenously (0.9% sodium chloride 200 ml slow infusion for 20 minutes) |
| 8IU intranasal oxytocin | EXPERIMENTAL | Using a double-dummy design participants will be administered 8IU oxytocin liquid delivered with the OptiNose Breath Powered Bi directional liquid device and IV placebo (0.9% sodium chloride, 200 ml slow infusion for 20 minutes) |
| 24IU intranasal oxytocin | EXPERIMENTAL | Using a double-dummy design participants will be administered 24IU oxytocin liquid delivered with the OptiNose Breath Powered Bi directional liquid device and IV placebo (0.9% sodium chloride, 200 ml slow infusion for 20 minutes) |
| Name | Type | Description |
|---|---|---|
| 8IU intranasal oxytocin | DRUG | - |
| 24 IU intranasal oxytocin | DRUG | - |
| 1 IU intravenous oxytocin | DRUG | - |
| Placebo | DRUG | - |
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 abnormal...