A Pharmacokinetic Study of Intravenous and Intranasal Oxytocin in Healthy Subjects

NCT05672667 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: IRB000899381P01NS119159-01A1
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteer Study

Keywords

Acute Pain; Chronic Pain; Intravenous Oxytocin; Intranasal Oxytocin

Outcome Measures

Primary Outcomes (21)

• 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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  60 minutes after intranasal oxytocin administration

Study Arms (1)

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.

Drug: intravenous oxytocin; Drug: intranasal oxytocin

Interventions

intravenous oxytocin DRUG

Oxytocin given by intravenous route

Also known as: Pitocin

Oxytocin Administration (Intravenous, then Intranasal)

intranasal oxytocin DRUG

Oxytocin given by intranasal administration

Also known as: TNX-1900

Oxytocin Administration (Intravenous, then Intranasal)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

• 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.

  PMID: 40121179 DERIVED

MeSH Terms

Conditions

Acute Pain; Chronic Pain

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Generalizability is limited by the single center design, lack of severely obese subjects, and, despite recruitment efforts, lack of race and ethnic diversity.

Results Point of Contact

• Title: Dr. James Eisenach
• Organization: Wake Forest University School of Medicine

jimeisenach@gmail.com

336-716-4182

Study Officials

• James C Eisenach, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each subject will receive 14 micrograms of oxytocin intravenously over 30 minutes and 102 micrograms of oxytocin intranasally.

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 5, 2023
• Study Start: February 27, 2023
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: February 17, 2025
• Results First Posted: August 6, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will become available upon publication or upon posting results in ClinicalTrials.gov, whichever comes first, with no expiration.
• Access Criteria: These data are freely shared to all and will be posted at the URL below

Locations

US (1)