A Study of Oxytocin PK After IV Administration in Healthy Subjects and Advanced Knee Arthritis Subjects

What Was Tested

The trial (phase 2) is built around Oxytocin.

It had 1 arm (groups): Oxytocin (experimental).

The registry classes the interventions as drug.

More on the Plan

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

Participants will get a 10 minute infusion through one of the IVs of oxytocin and blood will be taken several times over the next 120 minutes and the amount of oxytocin measured in the blood samples.

Investigators will also do some tests to get a rough idea of how oxytocin changes perceptions on the skin and how this relates to the amount of oxytocin in the blood at the same time.

In the first the study team will study a painful perception by placing a probe on the skin and heating it to 113 degrees F for 5 minutes.

Who 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: 1\. Male or female \> 18 and \< 75 years of age, Body Mass Index (BMI) \<40.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: 4\. subjects with neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis.

How the Study Was Run

The set-up was single-group and open-label.

Nothing was hidden in this open-label Oxytocin study: the participants and staff both knew the treatment.

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

It started in 2023-01 with completion listed for 2024-01.

Its stated primary purpose is basic science.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Oxytocin in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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