NCT05672667

A Pharmacokinetic Study of Intravenous and Intranasal Oxytocin in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is an unblinded, sequential study of subjects; all participants will receive an infusion of oxytocin and intranasal administration of oxytocin 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. Participants will come to the Clinical Research Unit (CRU) on study day 1 and have two IVs inserted; one in each arm. Participants will get a 30 minute infusion through one of the IV catheters of oxytocin and blood will be taken several times over the next 120 minutes, plasma separated, and the amount of oxytocin measured in the plasma samples. Participants will come to the CRU on study day 2 and have one IV inserted; in the arm. Participants will self administer intranasal oxytocin and blood will be taken several times over the next 60 minutes and the amount of oxytocin measured in the plasma samples. This information will be analyzed by another group at Stanford University under a data sharing agreement between the institutions and funded by a grant from the National Institutes of Health. Compartmental modeling will be performed using NONMEM to describe the change in oxytocin concentrations over time. The effect of subject age, sex, race, ethnicity and weight on the pharmacokinetics of oxytocin will be examined, since these factors can affect pharmacokinetics and are important to better adjust the dose of drug to the individual. The main purpose of this study is to determine the amount of oxytocin in plasma after IV and i.n. administration. The research participants will not benefit from this study, but the knowledge investigators get will be important to adjust oxytocin dose to individuals, and to be able to calculate plasma oxytocin concentrations after various doses in the future. The sample size chosen is needed to get an accurate estimate for the parameters in the pharmacokinetic model for the population, not just the subjects in this study.

Conditions

• Healthy Volunteer Study

Interventions

Type	Name	Description
DRUG	intravenous oxytocin	Oxytocin given by intravenous route
DRUG	intranasal oxytocin	Oxytocin given by intranasal administration

Timeline

• Start date: 2023-02-27
• Primary completion: 2023-11-01
• Completion: 2023-11-01
• First posted: 2023-01-05
• Last updated: 2025-02-17
• Results posted: 2024-08-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study