Healthy Women of Child Bearing PotentialPhase 1NCT02911480
Assessment of Pharmacokinetics and Bioavailability of Carbon-14 ([14C])-Labelled Oxytocin
A Phase 1 study testing Oxytocin in people with Healthy Women of Child Bearing Potential, run by Oxytone Bioscience BV.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Women of Child Bearing Potential
- What is being tested?
- Oxytocin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to 31 Aug 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
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.
- Conditions
- Healthy Women of Child Bearing Potential
- Being tested
- Oxytocin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
| Study group | Role | What they receive |
|---|---|---|
| oxytocin intravenous 0.1 IU | Experimental | single dose of 0.1 International Units (IU) intravenous (IV) oxytocin Receives: Drug: Oxytocin |
| oxytocin intravenous 1 IU | Experimental | single dose of 1 IU IV oxytocin Receives: Drug: Oxytocin |
| oxytocin intravenous 10 IU | Experimental | single dose of 10 IU IV oxytocin Receives: Drug: Oxytocin |
| oxytocin tablet 20 IU | Experimental | single dose of 20 IU tablet oxytocin Receives: Drug: Oxytocin |
| oxytocin tablet 200 IU | Experimental | single dose of 200 IU tablet oxytocin Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
pharmacokinetics (PK) parameter for oxytocin: maximum plasma concentration (Cmax)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Day 1, predose and at t=3, 7, 10, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, 360, 480 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study startApr 2016 (estimated)
- Primary completionFeb 2017 (estimated)
- Study completion31 Aug 2017
Why it stopped: Study/financial issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Women of Child Bearing PotentialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxytone Bioscience BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02911480
- Sponsor's protocol ID
- OXB-001
- Status last verified
- Apr 2018
- First submitted
- 16 Sep 2016
- Last updated
- 6 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Pharmacokinetics and Bioavailability of Carbon-14 ([14C])-Labelled Oxytocin
- ClinicalTrials.gov ID
- NCT02911480
- Acronym / sponsor ID
- OXB-001
- Conditions
- Healthy Women of Child Bearing Potential
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study/financial issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Oxytone Bioscience BVIndustry (pharma, biotech, devices)
- Study start
- Apr 2016 (estimated)
- Primary completion
- Feb 2017 (estimated)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 22 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| oxytocin intravenous 0.1 IU | Experimental | Drug: Oxytocinsingle dose of 0.1 International Units (IU) intravenous (IV) oxytocin |
| oxytocin intravenous 1 IU | Experimental | Drug: Oxytocinsingle dose of 1 IU IV oxytocin |
| oxytocin intravenous 10 IU | Experimental | Drug: Oxytocinsingle dose of 10 IU IV oxytocin |
| oxytocin tablet 20 IU | Experimental | Drug: Oxytocinsingle dose of 20 IU tablet oxytocin |
| oxytocin tablet 200 IU | Experimental | Drug: Oxytocinsingle dose of 200 IU tablet oxytocin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxytocin | Drug | oxytocin intravenous 0.1 IU, oxytocin intravenous 1 IU, oxytocin intravenous 10 IU, oxytocin tablet 20 IU, oxytocin tablet 200 IU |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oxytocin in people with Healthy Women of Child Bearing Potential, run by Oxytone Bioscience BV.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2018.