PK Sampling After IV Oxytocin and Effects on Sensory Function in Healthy Volunteers

NCT03929367 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB00056413
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal of this protocol is to model change in oxytocin concentrations in plasma after intravenous (IV) administration. Additional measurements will be performed on sensory function that could be influenced by oxytocin during later time periods when blood samples are widely separated by time. This protocol will describe the pharmacokinetics (PK) of intravenous oxytocin in healthy adult men and adult,non-pregnant women. PK samples will be obtained after an injection of intravenous oxytocin 10 IU over 60 seconds. Blood will be drawn for the PK samples prior to the oxytocin administration and then 11 times after administration. There are two additional measures which will assess two different aspects of sensory function. MEASURE 1: Light Touch Frequency Threshold In order to determine the highest frequency that specific nerve fibers can respond to, a simple device that produces an oscillatory / vibratory stimulus will be used on the hand. The subject places fingertips, palm, and palm side of the wrist sequentially and the device is set to slowly decrease the frequency of vibration from 1 kHz until the subject first perceives this. This is repeated three times at each site and takes less than 5 minutes in total. This will be performed before the oxytocin administration and 6 times after the administration of IV Oxytocin. MEASURE 2: Sustained Heat The surface of the skin of the forearm or leg is heated to 113°F using a computer controlled thermode for a period of 5 minutes. This will be done before the IV Oxytocin and 4 times after the administration. A set of random thermal temperatures (98°F-122°F) will also be applied to the skin of the leg or forearm before the IV Oxytocin administration and 4 times after administration of IV Oxytocin.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (11)

• Oxytocin Concentration

  Plasma concentrations of oxytocin at defined times after intravenous infusion

  2 minutes

• Oxytocin Concentration

  Plasma concentrations of oxytocin at defined times after intravenous infusion

  5 minutes

• Oxytocin Concentration

  Plasma concentrations of oxytocin at defined times after intravenous infusion

  10 minutes

• Oxytocin Concentration

  Plasma concentrations of oxytocin at defined times after intravenous infusion

  15 minutes

• Oxytocin Concentration

  Plasma concentrations of oxytocin at defined times after intravenous infusion

  30 minutes

• Oxytocin Concentration

  Plasma concentrations of oxytocin at defined times after intravenous infusion

  45 minutes

• Oxytocin Concentration

  Plasma concentrations of oxytocin at defined times after intravenous infusion

  60 minutes

• Oxytocin Concentration

  Plasma concentrations of oxytocin at defined times after intravenous infusion

  90 minutes

• Oxytocin Concentration

  Plasma concentrations of oxytocin at defined times after intravenous infusion

  120 minutes

• Oxytocin Concentration

  Plasma concentrations of oxytocin at defined times after intravenous infusion

  180 minutes

• Oxytocin Concentration

  Plasma concentrations of oxytocin at defined times after intravenous infusion

  240 minutes

Secondary Outcomes (26)

• Light Touch Frequency Threshold

  5 minutes

• Light Touch Frequency Threshold

  20 minutes

• Light Touch Frequency Threshold

  45 minutes

• Light Touch Frequency Threshold

  60 minutes

• Light Touch Frequency Threshold

  120 minutes

Study Arms (1)

Oxytocin (Pitocin®), 10 IU

OTHER

Oxytocin 10 IU administered once per intravenous injection

Drug: Oxytocin

Interventions

Oxytocin DRUG

Single IV administration of oxytocin

Also known as: Pitocin

Oxytocin (Pitocin®), 10 IU

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female \> 18 and \< 60 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 I or II
• Normal blood pressure (systolic 90-140 mmHg; diastolic 50-90 mmHg) resting heart rate 45-100 beats per minute) without medication
• 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

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 serum pregnancy test at screening visit), women who are currently nursing or lactating, women that have been pregnant within 2 years
• Subjects with neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Medical Center

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

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

Technical failure in one individual resulting in uninterpretable pain scores to sustained heat as a secondary outcome.

Results Point of Contact

• Title: Dr. James Eisenach
• Organization: Wake Forest Health Sciences

eisenach@wakehealth.edu

3367164182

Study Officials

• James Eisenach, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single intravenous administration of oxytocin (Pitocin®), 10 IU

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: April 26, 2019
• Study Start: May 10, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: May 13, 2021
• Results First Posted: April 19, 2021

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)