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NCT05672667 · ClinicalTrials.gov registry record · Phase 1
A Pharmacokinetic Study of Intravenous and Intranasal Oxytocin in Healthy Subjects
A Phase 1 study of Healthy Volunteer Study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT05672667: Completed Phase 1 study of Healthy Volunteer Study, sponsored by Wake Forest University Health Sciences.
NCT05672667 is a Phase 1 study of Healthy Volunteer Study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 25 participants, below the 34-participant average among 9 other Healthy Volunteer Study trials with a reported enrollment target (26% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05672667, a Phase 1 study of Healthy Volunteer Study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Conditions Studied
Interventions
- DRUG intravenous oxytocin
- DRUG intranasal oxytocin
Study Locations (1)
North Carolina
- Wake Forest Baptist Health - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2023-02-27 |
| Est. Completion | 2023-11-01 |
| Phase | Phase 1 |
What the finished NCT05672667 record still lists
NCT05672667 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 34-participant average among 9 other Healthy Volunteer Study trials with a reported enrollment target (26% lower).
The record links to 1 condition, with Healthy Volunteer Study appearing as the primary indexed condition, and to 2 interventions - of which intravenous oxytocin is the first listed.
NCT05672667 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT05672667 about?
NCT05672667 is a clinical study titled "A Pharmacokinetic Study of Intravenous and Intranasal Oxytocin in Healthy Subjects". 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...
What is the current status of trial NCT05672667?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2023-02-27. Estimated completion is 2023-11-01.
What conditions does trial NCT05672667 study?
This clinical trial studies the following conditions: Healthy Volunteer Study.
What interventions are being tested in trial NCT05672667?
The interventions under investigation include: intravenous oxytocin (DRUG), intranasal oxytocin (DRUG).
Who is sponsoring clinical trial NCT05672667?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05672667 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05672667's enrollment target sits among peer trials
25 7th of 9 higher than 3 of 9 other Healthy Volunteer Study trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteer Study trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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