A Study of Oxytocin PK After IV Administration in Healthy Subjects and Advanced Knee Arthritis Subjects

NCT04429880 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: IRB00065787
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main purpose of this study is to sample the blood and calculate the pharmacokinetics (PK) of oxytocin. This is an unblinded, sequential study of subjects, all of whom will receive an intravenous (IV) infusion of oxytocin (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 with knee arthritis so severe that they may need joint replacement are recruited for a one day study. Each study participant will have 2 IV catheters placed (one in each arm). After placement of the IV catheters and infusion of oxytocin will be given over a 10 minute period. Blood samples will be taken before the infusion begins and several times during and after the infusion. The blood will be drawn through the second IV catheter. The investigators will also do some tests to get a rough idea of how oxytocin changes perceptions on the skin and how this relates to the amount of oxytocin in the blood at the same time. Two kinds of perceptions will be studied. First, the investigators will study a painful perception by placing a probe on the skin and heating it to 113 degrees Fahrenheit for 5 minutes. Each study participant will score any pain that is experienced on a 0 to 10 scale, and most people find that pain rises during the 5 minutes, but remains mild, usually around only 1 or 2 on the 0 to 10 scale. Secondly, the investigators will study the perception of vibration, like one feels with a tuning fork on the skin. For this the investigators will put a controlled vibration device on the arm and start the vibration at such a high frequency (1000 times per second) that it cannot be felt as vibrating. The investigators will slow the frequency until the study participant first feels vibration, then turn off the machine and record this threshold frequency where it is first felt.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (11)

• Pharmacokinetics of oxytocin in serum

  Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.

  1 minute after oxytocin infusion initiated

• Pharmacokinetics of oxytocin in serum

  Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.

  2 minute after oxytocin infusion initiated

• Pharmacokinetics of oxytocin in serum

  Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.

  5 minute after oxytocin infusion initiated

• Pharmacokinetics of oxytocin in serum

  Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.

  10 minute after oxytocin infusion initiated

• Pharmacokinetics of oxytocin in serum

  Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.

  12 minute after oxytocin infusion initiated

• Pharmacokinetics of oxytocin in serum

  Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.

  15 minute after oxytocin infusion initiated

• Pharmacokinetics of oxytocin in serum

  Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.

  20 minute after oxytocin infusion initiated

• Pharmacokinetics of oxytocin in serum

  Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.

  30 minute after oxytocin infusion initiated

• Pharmacokinetics of oxytocin in serum

  Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.

  60 minute after oxytocin infusion initiated

• Pharmacokinetics of oxytocin in serum

  Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.

  90 minute after oxytocin infusion initiated

• Pharmacokinetics of oxytocin in serum

  Blood will be sampled at specified intervals during and after the infusion. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration.

  120 minute after oxytocin infusion initiated

Secondary Outcomes (10)

• Pharmacodynamics of heat pain after oxytocin

  30 minutes after oxytocin infusion initiated

• Pharmacodynamics of heat pain after oxytocin

  60 minutes after oxytocin infusion initiated

• Pharmacodynamics of heat pain after oxytocin

  90 minutes after oxytocin infusion initiated

• Pharmacodynamics of heat pain after oxytocin

  120 minutes after oxytocin infusion initiated

• Pharmacodynamics of heat pain after oxytocin

  180 minutes after oxytocin infusion initiated

Study Arms (1)

Oxytocin

EXPERIMENTAL

Oxytocin 17 micrograms infusion over 10 minutes

Drug: Oxytocin

Interventions

Oxytocin DRUG

Oxytocin given by intravenous route

Also known as: Pitocin

Oxytocin

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, 2, or 3.
• \. For healthy volunteers, normal blood pressure (systolic 90-140 mmHg; diastolic 50-90 mmHg) resting heart rate 45-100 beats per minute) without medication. For knee arthritis subjects, normal blood pressure or, for those with hypertension, pressure controlled with anti-hypertensives 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 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

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• James C Eisenach, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participant will receive the same dose of oxytocin 17 micrograms via a 10 minute intravenous infusion

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 12, 2020
• Study Start: January 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: August 12, 2025

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share