CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 25 enrolled
Drug / intervention
intravenous oxytocin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05672667
NCT05672667Phase 1Completed

A Pharmacokinetic Study of Intravenous and Intranasal Oxytocin in Healthy Subjects

Wake Forest University Health Sciences·interventional·Posted Jan 5, 2023·Updated Feb 17, 2025

In Brief

A Phase 1 clinical trial evaluating intravenous oxytocin and intranasal oxytocin for Healthy Volunteer Study. Completed, enrolled 25 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedJan 5, 2023
Enrollment StartFeb 27, 2023
Primary CompletionNov 1, 2023
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 3.5 years ago

Interventions

intravenous oxytocindrug

Oxytocin given by intravenous route

intranasal oxytocindrug

Oxytocin given by intranasal administration