PK Sampling After IV Oxytocin and Effects on Sensory Function in Healthy Volunteers
Status:
Completed
Trial end date:
2020-03-01
Target enrollment:
Participant gender:
Summary
The primary goal of this protocol is to model change in oxytocin concentrations in plasma
after intravenous (IV) administration. Additional measurements will be performed on sensory
function that could be influenced by oxytocin during later time periods when blood samples
are widely separated by time. This protocol will describe the pharmacokinetics (PK) of
intravenous oxytocin in healthy adult men and adult,non-pregnant women. PK samples will be
obtained after an injection of intravenous oxytocin 10 IU over 60 seconds.
Blood will be drawn for the PK samples prior to the oxytocin administration and then 11 times
after administration.
There are two additional measures which will assess two different aspects of sensory
function.
MEASURE 1: Light Touch Frequency Threshold In order to determine the highest frequency that
specific nerve fibers can respond to, a simple device that produces an oscillatory /
vibratory stimulus will be used on the hand. The subject places fingertips, palm, and palm
side of the wrist sequentially and the device is set to slowly decrease the frequency of
vibration from 1 kHz until the subject first perceives this. This is repeated three times at
each site and takes less than 5 minutes in total. This will be performed before the oxytocin
administration and 6 times after the administration of IV Oxytocin.
MEASURE 2: Sustained Heat The surface of the skin of the forearm or leg is heated to 113°F
using a computer controlled thermode for a period of 5 minutes. This will be done before the
IV Oxytocin and 4 times after the administration. A set of random thermal temperatures
(98°F-122°F) will also be applied to the skin of the leg or forearm before the IV Oxytocin
administration and 4 times after administration of IV Oxytocin.