A Pharmacokinetic Study of Intravenous and Intranasal Oxytocin in Healthy Subjects

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.

Timeline

Start

2023-02-27

Primary completion

2023-11-01

Completion

2023-11-01

Publications

• Shafer SL, Ririe DG, Miller S, Curry RS, Hsu DT, Sullivan GM, Eisenach JC. Plasma pharmacokinetics of intravenous and intranasal oxytocin in nonpregnant adults. Br J Anaesth. 2025 May;134(5):1513-1522. doi: 10.1016/j.bja.2024.12.046. Epub 2025 Mar 21.

Drugs

Indications

No indication recorded.