- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02911480
Assessment of Pharmacokinetics and Bioavailability of Carbon-14 ([14C])-Labelled Oxytocin
April 4, 2018 updated by: Oxytone Bioscience BV
The current study is designed as a phase I multiple dose study to evaluate the pharmacokinetics and bioavailability of [14C]-labelled oxytocin in healthy women.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 43 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Non-smoking women of child bearing potential (WOCBP)
- Body mass index (BMI) between ≥ 18.0 and ≤ 30.0 kg/m2
- Subject must voluntarily sign a written informed consent agreement approved by the Independent Ethics Committee (IEC) after explanation of the nature and objectives of the study and before any study specific procedure
- Subject must be in good physical and mental health as judged by the Investigator based on evaluation of medical and gynecological history, physical examination, clinical laboratory, ECG, and vital signs data
- Subject is willing and able to comply with all conditions and requirements of the study
Exclusion Criteria:
- Lactation and/or pregnancy in the previous 6 months before screening, whichever is applicable
- Intention to become pregnant during the study or within 1 months after the follow up visit
- History of, or existing thromboembolic, cardiovascular or cerebrovascular disorder
- Treatment for any major psychiatric disorder in the previous 12 months or use of antidepressant medication before screening
- Any clinically significant abnormality following review of medical history, laboratory results and physical examination at screening as judged by the Investigator
- Conditions or disorders that might affect the absorption, distribution, metabolism or excretion of the study drugs
- Contraindications for the use of oxytocin
- Hypersensitivity to the active substances or to any of the excipients of the investigational product or reference therapy
- Present use or use within 30 days before the start of the study medication of one or more of the following medications: antihypertensive drugs, anti-coagulant therapy, medication that could affect myometrial contractility, sex steroids, prostaglandins and its analogues, inhalation anesthetics, vasoconstrictors/sympathomimetics and caudal anesthetics, vasopressin-like drugs
- Use of any prescribed or over-the-counter medication within 14 days before Day 1
- Administration of any other investigational drug within 3 months before Day 1 or participation in 3 or more clinical trials in the 10 months before Day 1
- Loss of more than 500 milliliters (mL) blood during the 3 months before Day 1, or intention to donate blood in the 3 months after completing the study
- Subjects with a positive test result for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) at screening
- Subjects with a history of alcohol or drug abuse or with a positive result at screening, for tests of alcohol intake or drugs of abuse
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: oxytocin intravenous 0.1 IU
single dose of 0.1 International Units (IU) intravenous (IV) oxytocin
|
|
Experimental: oxytocin intravenous 1 IU
single dose of 1 IU IV oxytocin
|
|
Experimental: oxytocin intravenous 10 IU
single dose of 10 IU IV oxytocin
|
|
Experimental: oxytocin tablet 20 IU
single dose of 20 IU tablet oxytocin
|
|
Experimental: oxytocin tablet 200 IU
single dose of 200 IU tablet oxytocin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
pharmacokinetics (PK) parameter for oxytocin: maximum plasma concentration (Cmax)
Time Frame: Day 1, predose and at t=3, 7, 10, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, 360, 480 minutes.
|
Day 1, predose and at t=3, 7, 10, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, 360, 480 minutes.
|
pharmacokinetics (PK) parameter for oxytocin: time to Cmax (tmax)
Time Frame: Day 1, predose and at t=3, 7, 10, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, 360, 480 minutes.
|
Day 1, predose and at t=3, 7, 10, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, 360, 480 minutes.
|
pharmacokinetics (PK) parameter for oxytocin: area under the plasma-concentration time curve (AUC)
Time Frame: Day 1, predose and at t=3, 7, 10, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, 360, 480 minutes.
|
Day 1, predose and at t=3, 7, 10, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, 360, 480 minutes.
|
pharmacokinetics (PK) parameter for oxytocin: terminal half-life (t1/2)
Time Frame: Day 1, predose and at t=3, 7, 10, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, 360, 480 minutes.
|
Day 1, predose and at t=3, 7, 10, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, 360, 480 minutes.
|
pharmacokinetics (PK) parameter for oxytocin: bioavailability (F)
Time Frame: Day 1, predose and at t=3, 7, 10, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, 360, 480 minutes.
|
Day 1, predose and at t=3, 7, 10, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, 360, 480 minutes.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
April 1, 2016
Primary Completion (Anticipated)
February 1, 2017
Study Completion (Actual)
August 31, 2017
Study Registration Dates
First Submitted
September 16, 2016
First Submitted That Met QC Criteria
September 20, 2016
First Posted (Estimate)
September 22, 2016
Study Record Updates
Last Update Posted (Actual)
April 6, 2018
Last Update Submitted That Met QC Criteria
April 4, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OXB-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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