A Pharmacokinetic Study of Intravenous and Intranasal Oxytocin in Healthy Subjects
Status:
Not yet recruiting
Trial end date:
2024-02-01
Target enrollment:
Participant gender:
Summary
The main purpose of this study is to sample blood and model the plasma pharmacokinetics (PK)
of a single dose of intravenous (IV) oxytocin and a single dose of intranasal (i.n.)
oxytocin.
This is an unblinded study of subjects, all of whom will receive an intravenous (IV) infusion
and intranasal (i.n.) dose of oxytocin (a 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 are recruited for a two day study. Each study
participant will have 2 IV catheters placed (one in each arm) for the day of IV oxytocin
dosing and 1 IV catheter on the day of i.n. oxytocin dosing. After placement of the IV
catheters, an infusion of oxytocin will be given over a 30 minute period. Blood samples will
be taken after the infusion begins and several times during and after the infusion. The blood
will be drawn through the IV catheter not used for the oxytocin infusion. For the intranasal
oxytocin administration day, 1 IV catheter will be placed and several blood samples will be
taken after administration.
Phase:
Phase 1
Details
Lead Sponsor:
Wake Forest University Health Sciences
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)