Healthy Volunteer StudyPhase 1NCT05672667
A Pharmacokinetic Study of Intravenous and Intranasal Oxytocin in Healthy Subjects
A Phase 1 study testing intravenous oxytocin and intranasal oxytocin in people with Healthy Volunteer Study, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer Study
- What is being tested?
- intravenous oxytocin and intranasal oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2023to 1 Nov 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female > 18 and < 75 years of age, Body Mass Index (BMI) <40.
- Generally in good health as determined by the Principal Investigator based on prior medical history, American Society of Anesthesiologists physical status 1 or 2.
- For healthy volunteers, normal blood pressure (systolic 100-140 mmHg; diastolic 60-90 mmHg) resting heart rate 45-90 beats per minute) without medication. For those with hypertension, blood pressure controlled with anti-hypertensive medication and with a resting heart rate 45-100 beats per minute.
- Female subjects of child-bearing potential and those < 1 year post-menopausal, must be practicing highly effective methods of birth control such as hormonal methods (e.g., combined oral, implantable, injectable, or transdermal contraceptives), double barrier methods (e.g., condoms, sponge, diaphragm, or vaginal ring plus spermicidal jellies or cream), or total abstinence from heterosexual intercourse for a minimum of 1 full cycle before study drug administration.
Who cannot join
- Hypersensitivity, allergy, or significant reaction to any ingredient of Pitocin®
- Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the Principal Investigator, would place the subject at increased risk (active gynecologic disease in which increased tone would be detrimental e.g., uterine fibroids with ongoing bleeding), compromise the subject's compliance with study procedures, or compromise the quality of the data
- Women who are pregnant (positive result for urine pregnancy test at visit 1), women who are currently nursing or lactating, women that have been pregnant within 2 years
- Subjects with neuropathy, chronic pain (being treated on a daily basis), diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis.
- Subjects with current or history of ventricular tachycardia, atrial fibrillation or prolonged QT interval.
- Subjects with past or current history of hyponatremia or at risk for hyponatremia; anyone taking thiazide diuretics, loop diuretics, combination diuretics, lithium, carbamazepine, enalapril, Ramipril, celecoxib, temazepam, gliclazide, glimepiride, glibenclamide, glipizide, omeprazole, pantoprazole, desmopressin, Selective serotonin reuptake inhibitors (SSRI's) , Monoamine oxidase inhibitors (MAOI), or the recreational drug ecstasy.
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- Subjects with a known latex allergy.
- History of chronic nasal obstruction or local pathology in nostril pathway which, in the opinion of the investigator, would prevent appropriate nasal administration of the study drug.
- Use of over the counter nasal products (ie. Saline spray, Neti-Pot, etc.) or intranasal corticosteroid medications during the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
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.
Read the 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
- Being tested
- intravenous oxytocin, intranasal oxytocin
- Keywords
- Acute Pain, Chronic Pain, Intravenous Oxytocin, Intranasal Oxytocin
- Medical subject headings
- Acute Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous oxytocinDrug
Also called Pitocin
Oxytocin given by intravenous route
intranasal oxytocinDrug
Also called TNX-1900
Oxytocin given by intranasal administration
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin Administration (Intravenous, then Intranasal) | Experimental | Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day. Receives: Drug: intravenous oxytocin; Drug: intranasal oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Oxytocin Concentration 2 Minutes After Infusion Initiated
Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Measured: 2 minutes after oxytocin infusion initiated
Plasma Oxytocin Concentration 5 Minutes After Infusion Initiated
Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Measured: 5 minutes after oxytocin infusion initiated
Plasma Oxytocin Concentration 10 Minutes After Infusion Initiated
Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Measured: 10 minutes after oxytocin infusion initiated
Plasma Oxytocin Concentration 20 Minutes After Infusion Initiated
Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Measured: 20 minutes after oxytocin infusion initiated
Plasma Oxytocin Concentration 30 Minutes After Infusion Initiated
Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Measured: 30 minutes after oxytocin infusion initiated
Plasma Oxytocin Concentration 40 Minutes After Infusion Initiated
Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Measured: 40 minutes after oxytocin infusion initiated
Plasma Oxytocin Concentration 50 Minutes After Infusion Initiated
Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Measured: 50 minutes after oxytocin infusion initiated
Plasma Oxytocin Concentration 65 Minutes After Infusion Initiated
Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Measured: 65 minutes after oxytocin infusion initiated
Plasma Oxytocin Concentration 90 Minutes After Infusion Initiated
Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Measured: 90 minutes after oxytocin infusion initiated
Plasma Oxytocin Concentration 120 Minutes After Infusion Initiated
Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Measured: 120 minutes after oxytocin infusion initiated
Plasma Oxytocin Concentration 1 Minute After First Intranasal Puffs
Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Measured: 1 minute after intranasal oxytocin administration
Plasma Oxytocin Concentration 2 Minutes After First Intranasal Puffs
Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Measured: 2 minutes after intranasal oxytocin administration
Plasma Oxytocin Concentration 5 Minutes After First Intranasal Puffs
Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Measured: 5 minutes after intranasal oxytocin administration
Plasma Oxytocin Concentration 7 Minutes After First Intranasal Puffs
Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Measured: 7 minutes after intranasal oxytocin administration
Plasma Oxytocin Concentration 10 Minutes After First Intranasal Puffs
Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Measured: 10 minutes after intranasal oxytocin administration
Plasma Oxytocin Concentration 15 Minutes After First Intranasal Puffs
Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Measured: 15 minutes after intranasal oxytocin administration
Plasma Oxytocin Concentration 20 Minutes After First Intranasal Puffs
Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Measured: 20 minutes after intranasal oxytocin administration
Plasma Oxytocin Concentration 25 Minutes After First Intranasal Puffs
Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Measured: 25 minutes after intranasal oxytocin administration
Plasma Oxytocin Concentration 35 Minutes After First Intranasal Puffs
Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Measured: 35 minutes after intranasal oxytocin administration
Plasma Oxytocin Concentration 45 Minutes After First Intranasal Puffs
Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Measured: 45 minutes after intranasal oxytocin administration
Plasma Oxytocin Concentration 60 Minutes After First Intranasal Puffs
Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Measured: 60 minutes after intranasal oxytocin administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start27 Feb 2023
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Volunteer StudyStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each subject will receive 14 micrograms of oxytocin intravenously over 30 minutes and 102 micrograms of oxytocin intranasally.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James C Eisenach, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05672667
- Sponsor's protocol ID
- IRB00089938
- Other IDs
- 1P01NS119159-01A1
- Status last verified
- Dec 2023
- First submitted
- 20 Dec 2022
- Last updated
- 17 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan Description: Statistical programs in the data analysis will be written in R. The software and anonymized data will be included both as digital supplements in the published papers and will be posted on GitHub under github.com/StevenLShafer. Interested investigators will be able to reproduce the published analyses from these files. Consistent with the posting of software and data to the OpenTCI initiative, the software and de-identified data will be made available with "no strings attached," enabling investigators to freely use the data to inform or supplement additional research without restriction. Data to be made available are oxytocin dose, times of sampling (relative to the start of dosing), plasma oxytocin concentrations at those times for each subject, and age, weight, and sex for each subject.
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.
PubMed 40121179
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic Study of Intravenous and Intranasal Oxytocin in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05672667
- Acronym / sponsor ID
- IRB00089938
- Conditions
- Healthy Volunteer Study
- Keywords
- Acute Pain, Chronic Pain, Intravenous Oxytocin, Intranasal Oxytocin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 5 Jan 2023 (actual)
- Results
- Posted 6 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each subject will receive 14 micrograms of oxytocin intravenously over 30 minutes and 102 micrograms of oxytocin intranasally.
| Arm | Type | Receives |
|---|---|---|
| Oxytocin Administration (Intravenous, then Intranasal) | Experimental | Drug: intravenous oxytocin, Drug: intranasal oxytocinOxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female > 18 and < 75 years of age, Body Mass Index (BMI) <40.
- Generally in good health as determined by the Principal Investigator based on prior medical history, American Society of Anesthesiologists physical status 1 or 2.
- For healthy volunteers, normal blood pressure (systolic 100-140 mmHg; diastolic 60-90 mmHg) resting heart rate 45-90 beats per minute) without medication. For those with hypertension, blood pressure controlled with anti-hypertensive medication and with a resting heart rate 45-100 beats per minute.
- Female subjects of child-bearing potential and those < 1 year post-menopausal, must be practicing highly effective methods of birth control such as hormonal methods (e.g., combined oral, implantable, injectable, or transdermal contraceptives), double barrier methods (e.g., condoms, sponge, diaphragm, or vaginal ring plus spermicidal jellies or cream), or total abstinence from heterosexual intercourse for a minimum of 1 full cycle before study drug administration.
Key exclusion criteria (9 listed)
- Hypersensitivity, allergy, or significant reaction to any ingredient of Pitocin®
- Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the Principal Investigator, would place the subject at increased risk (active gynecologic disease in which increased tone would be detrimental e.g., uterine fibroids with ongoing bleeding), compromise the subject's compliance with study procedures, or compromise the quality of the data
- Women who are pregnant (positive result for urine pregnancy test at visit 1), women who are currently nursing or lactating, women that have been pregnant within 2 years
- Subjects with neuropathy, chronic pain (being treated on a daily basis), diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis.
- Subjects with current or history of ventricular tachycardia, atrial fibrillation or prolonged QT interval.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravenous oxytocinAlso: PitocinOxytocin given by intravenous route | Drug | Oxytocin Administration (Intravenous, then Intranasal) |
| intranasal oxytocinAlso: TNX-1900Oxytocin given by intranasal administration | Drug | Oxytocin Administration (Intravenous, then Intranasal) |
Primary outcome
Plasma Oxytocin Concentration 2 Minutes After Infusion Initiated
Time frame: 2 minutes after oxytocin infusion initiated
Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Plasma Oxytocin Concentration 5 Minutes After Infusion Initiated
Time frame: 5 minutes after oxytocin infusion initiated
Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Plasma Oxytocin Concentration 10 Minutes After Infusion Initiated
Time frame: 10 minutes after oxytocin infusion initiated
Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Plasma Oxytocin Concentration 20 Minutes After Infusion Initiated
Time frame: 20 minutes after oxytocin infusion initiated
Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Plasma Oxytocin Concentration 30 Minutes After Infusion Initiated
Time frame: 30 minutes after oxytocin infusion initiated
Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Plasma Oxytocin Concentration 40 Minutes After Infusion Initiated
Time frame: 40 minutes after oxytocin infusion initiated
Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Plasma Oxytocin Concentration 50 Minutes After Infusion Initiated
Time frame: 50 minutes after oxytocin infusion initiated
Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Plasma Oxytocin Concentration 65 Minutes After Infusion Initiated
Time frame: 65 minutes after oxytocin infusion initiated
Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Plasma Oxytocin Concentration 90 Minutes After Infusion Initiated
Time frame: 90 minutes after oxytocin infusion initiated
Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Plasma Oxytocin Concentration 120 Minutes After Infusion Initiated
Time frame: 120 minutes after oxytocin infusion initiated
Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Plasma Oxytocin Concentration 1 Minute After First Intranasal Puffs
Time frame: 1 minute after intranasal oxytocin administration
Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Plasma Oxytocin Concentration 2 Minutes After First Intranasal Puffs
Time frame: 2 minutes after intranasal oxytocin administration
Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Plasma Oxytocin Concentration 5 Minutes After First Intranasal Puffs
Time frame: 5 minutes after intranasal oxytocin administration
Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Plasma Oxytocin Concentration 7 Minutes After First Intranasal Puffs
Time frame: 7 minutes after intranasal oxytocin administration
Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Plasma Oxytocin Concentration 10 Minutes After First Intranasal Puffs
Time frame: 10 minutes after intranasal oxytocin administration
Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Plasma Oxytocin Concentration 15 Minutes After First Intranasal Puffs
Time frame: 15 minutes after intranasal oxytocin administration
Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Plasma Oxytocin Concentration 20 Minutes After First Intranasal Puffs
Time frame: 20 minutes after intranasal oxytocin administration
Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Plasma Oxytocin Concentration 25 Minutes After First Intranasal Puffs
Time frame: 25 minutes after intranasal oxytocin administration
Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Plasma Oxytocin Concentration 35 Minutes After First Intranasal Puffs
Time frame: 35 minutes after intranasal oxytocin administration
Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Plasma Oxytocin Concentration 45 Minutes After First Intranasal Puffs
Time frame: 45 minutes after intranasal oxytocin administration
Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Plasma Oxytocin Concentration 60 Minutes After First Intranasal Puffs
Time frame: 60 minutes after intranasal oxytocin administration
Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40121179Shafer 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.
- Individual participant dataSharing planned: Yes. Plan Description: Statistical programs in the data analysis will be written in R. The software and anonymized data will be included both as digital supplements in the published papers and will be posted on GitHub under github.com/StevenLShafer. Interested investigators will be able to reproduce the published analyses from these files. Consistent with the posting of software and data to the OpenTCI initiative, the software and de-identified data will be made available with "no strings attached," enabling investigators to freely use the data to inform or supplement additional research without restriction. Data to be made available are oxytocin dose, times of sampling (relative to the start of dosing), plasma oxytocin concentrations at those times for each subject, and age, weight, and sex for each subject.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James C Eisenach, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing intravenous oxytocin and intranasal oxytocin in people with Healthy Volunteer Study, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Oxytocin Concentration 2 Minutes After Infusion Initiated (time frame: 2 minutes after oxytocin infusion initiated). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05672667, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.