A Pharmacokinetic Study of Intravenous and Intranasal Oxytocin in Healthy Subjects

What Was Tested

This registered phase 1 trial tested Oxytocin.

It had 1 arm (groups): Oxytocin Administration (Intravenous, then Intranasal) (experimental).

The registry classes the interventions as drug.

More on the Plan

Participants will come to the Clinical Research Unit (CRU) on study day 1 and have two IVs inserted; one in each arm.

Participants will get a 30 minute infusion through one of the IV catheters of oxytocin and blood will be taken several times over the next 120 minutes, plasma separated, and the amount of oxytocin measured in the plasma samples.

Participants will come to the CRU on study day 2 and have one IV inserted; in the arm.

Participants will self administer intranasal oxytocin and blood will be taken several times over the next 60 minutes and the amount of oxytocin measured in the plasma samples.

Who Took Part

Enrollment: 25 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Male or female \> 18 and \< 75 years of age, Body Mass Index (BMI) \<40.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: subjects with neuropathy, chronic pain (being treated on a daily basis), diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis; subjects with current or history of ventricular tachycardia, atrial fibrillation or prolonged qt interval; subjects with a known latex allergy.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Oxytocin study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2023-02-27 with completion listed for 2023-11-01.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Plasma Oxytocin Concentration 2 Minutes After Infusion Initiated (time frame: 2 minutes after oxytocin infusion initiated). Plasma Oxytocin Concentration 5 Minutes After Infusion Initiated (time frame: 5 minutes after oxytocin infusion initiated). Plasma Oxytocin Concentration 10 Minutes After Infusion Initiated (time frame: 10 minutes after oxytocin infusion initiated).

What This Means in Plain Language

Put simply, this is a phase 1 trial of Oxytocin in 25 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Oxytocin compound page, all human trials.