Oxytocin Pharmacokinetics After Intramuscular Injection

• Status: Withdrawn
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

In this study people with knee arthritis so severe that a joint replacement is needed are recruited for a one day study. Study participants will have an intravenous catheter (IV) inserted in the forearm. A single intramuscular (IM) injection of oxytocin (Pitocin®), 17 micrograms will be administered and blood samples will be taken several times over the next 120 minutes. The amount of oxytocin will be measured in the blood samples.

The main purpose of this study is to sample the blood, before and after the administration of oxytocin and calculate the pharmacokinetics (amount of oxytocin in the blood over time) of oxytocin.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Treatments: Oxytocin

Criteria

Inclusion Criteria:

• 1. Male or female > 18 and < 75 years of age, Body Mass Index (BMI) <40.

• 2. 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.

• 3. Normal blood pressure or, for those with hypertension, pressure controlled with anti-hypertensives and with a resting heart rate 45-100 beats per minute.

• 4. 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.

• 5. diagnosis of advanced knee arthritis

Exclusion Criteria:

• 1. Hypersensitivity, allergy, or significant reaction to any ingredient of Pitocin®

• 2. 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

• 3. 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

• 4. Subjects with neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis.