A Study of Oxytocin PK After IV Administration in Healthy Subjects and Advanced Knee Arthritis Subjects
Status:
Not yet recruiting
Trial end date:
2023-01-01
Target enrollment:
Participant gender:
Summary
The main purpose of this study is to sample the blood and calculate the pharmacokinetics (PK)
of oxytocin.
This is an unblinded, sequential study of subjects, all of whom will receive an intravenous
(IV) infusion of oxytocin (naturally occurring hormone that is made in the brain) with blood
samples taken thereafter in order to create a formula to describe the concentrations of
oxytocin in the blood over time (pharmacokinetics).
In this study healthy volunteers and people with knee arthritis so severe that they may need
joint replacement are recruited for a one day study. Each study participant will have 2 IV
catheters placed (one in each arm). After placement of the IV catheters and infusion of
oxytocin will be given over a 10 minute period. Blood samples will be taken before the
infusion begins and several times during and after the infusion. The blood will be drawn
through the second IV catheter.
The 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. Two kinds of perceptions will be studied. First, the investigators will study a
painful perception by placing a probe on the skin and heating it to 113 degrees Fahrenheit
for 5 minutes. Each study participant will score any pain that is experienced on a 0 to 10
scale, and most people find that pain rises during the 5 minutes, but remains mild, usually
around only 1 or 2 on the 0 to 10 scale. Secondly, the investigators will study the
perception of vibration, like one feels with a tuning fork on the skin. For this the
investigators will put a controlled vibration device on the arm and start the vibration at
such a high frequency (1000 times per second) that it cannot be felt as vibrating. The
investigators will slow the frequency until the study participant first feels vibration, then
turn off the machine and record this threshold frequency where it is first felt.