HealthyPhase 1NCT02236026
A Study With an Open-Label Active Control to Evaluate the Potential of Nestorone® to Delay Cardiac Repolarization in Healthy Female Volunteers
A Phase 1 study testing Supratherapuetic dose of Nestorone and Moxifloxacin in people with Healthy, run by Population Council at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the effect of Nestorone (NES) administered as an bolus injection on the corrected QT interval using Fridericia's formula (QTcF). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Supratherapuetic dose of Nestorone and Moxifloxacin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Dec 2015
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Is a premenopausal female, ≥ 18 to < 40 years of age at the time of Screening;
- Has a BMI ≥ 18.5 and ≤ 32 kg/m2 (weight ≥ 50 kg) at Screening
- Is in a state of general good health based on medical history and physical examination;
- Is regularly menstruating (cycles of 22 to 35 days duration) over the previous 6 months prior to Screening, as reported by the subject;
- If of childbearing potential, must be practicing an acceptable non-hormonal, method of birth control until the end of the study (Exit/Early Termination). Such methods include but are not limited to: Sexual abstinence; Male or female condom in combination with spermicidal foam/gel/cream/ suppository; Vasectomized or female partner; Diaphragm/cervical cap with spermicide; Bilateral tubal ligation sterilization at least 6 months before the screening visit, or an ESSURE or ADIANA procedure with an hysterosalpingography confirmation test at least 6 months before the screening visit; Copper intrauterine device.
- Is able to fulfill the requirements of the protocol, and indicates a willingness to participate in the study by providing written informed consent and an authorization to disclose PHI.
Who cannot join
- Is pregnant or lactating;
- Has hypersensitivity or allergy to NES, moxifloxacin, or related compounds, or any of the inactive ingredients used in the investigational product formulations;
- Has a contraindication to progestin or estrogen therapy;
- Has impaired hypothalamic-pituitary-adrenal reserve, or history of oral glucocorticoid replacement therapy in 12 months prior to Screening.
- Has experienced undiagnosed genital bleeding, excluding inter-menstrual spotting, within 6 months of Screening;
- Has undergone a gynecological examination, which results in clinically significant abnormalities, at Screening;
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- Has had treatment with oral, topical or vaginal steroid hormones (e.g., estrogens, progestogens, androgens [including dehydroepiandrosterone], corticosteroids) within 8 weeks prior to Screening, or treatment with injectable or implantable steroids at any time during the 6 months prior to Screening;
- Is currently using, or has used within 6 months prior to Screening, hormonal contraception or progestin intrauterine device.
- Has known or suspected carcinoma of the breast;
- Has benign or malignant liver tumors or acute liver disease;
- Has current or past thrombophlebitis or thromboembolic disorders or a family history of thromboembolic disorders;
- Has a personal history of myocardial disease, Long QT Syndrome or a personal or family history of Long QT Syndrome (e.g., Anderson-Tawil Syndrome [micrognathia, low set ears, clinodactyly]; Timothy's Syndrome [syndactyly and autism spectrum disorder];: Jervell/Lange-Nielsen Syndrome [bilateral hearing loss]; Romano-Ward Syndrome [fainting, seizures]), unexplained syncope or presyncope, or current or recurrent hypokalemia.
- Has a family history in genetically related grandparents, parents, uncles/aunts, cousins, or children of Long QT Syndrome, non-ischemic cardiomyopathy, or unexplained sudden death before 50 years of age.
- Has an abnormal 12-lead ECG, with clinically significant abnormalities of rate, rhythm, or conduction including: HR < 45 or > 90 beats per minute (bpm), after a 5 minute supine rest; PR interval > 220 ms; QRS interval > 120 ms; QTcF or corrected QT interval using Bazett's formula (to be determined by Investigator) > 450 ms; QTcF < 300 ms; Any degree of clinically significant fascicular block, bundle branch block, or intraventricular conduction delay; QRS and/or T wave that the Investigator judges to be unfavorable for consistently accurate QT measurements (e.g., indistinct QRS onset, low amplitude T wave, inverted or terminally inverted T wave, merged T/U waves, indistinct T wave offset, or prominent U wave that affects QT measurement); Neuromuscular artifact that cannot be readily eliminated;
- Has, on ECG, premature atrial or ventricular beats or other findings that in the Investigator's opinion represent clinically significant excessive HR variation;
- Has any clinically significant deviation from normal in any of the screening tests or initial exams that, in the opinion of the Investigator, might present a safety risk for participation or would confound analysis or interpretation of the study results;
- Has participated in a clinical study or used any investigational drug within the 60 days prior to Screening;
- Requires the use of medication, including over-the-counter products, or nutritional supplements, with the exception of aspirin, ibuprofen, and acetaminophen. Medications are not exclusionary if they are discontinued as described below; however, under no circumstance should medication be discontinued if doing so would place a subject at risk; Medications (including nutritional supplements) known to be moderate or potent inhibitor of cytochrome P450 (CYP) 3A4, or to prolong the QT/QTc interval, must be discontinued at least 21 days prior to study entry (Day -1 of Treatment Period 1); All other prescription medications must be discontinued at least 14 days prior to study entry (Day -1 of Treatment Period 1), unless in the opinion of the Investigator the concomitant use of such medication does not place the subject at risk and will not confound the collection, analysis, or interpretation of study data; Over-the-counter medications (including nutritional supplements) must be discontinued at least 7 days prior to study entry (Day -1 of Treatment Period 1);
- Foods or beverages containing alcohol, caffeine, xanthine, or grapefruit are not allowed within 48 hours of Day -1 of each treatment period.
- Has a positive hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) screen;
- Has a positive test for alcohol or drugs of abuse, or a history of known or suspected alcohol or drug abuse;
- Has used tobacco products within 6 months prior to Screening, or has a positive urine test for tobacco use;
- Has donated more than 400 mL of blood/plasma in the 60 days prior to Day -1 of Treatment Period 1;
- Is unable or unwilling to provide written informed consent or comply with the activities or instructions of the study;
- Is judged by the Investigator to be unsuitable for any reason.
Trial locations and contacts
1 site in 1 country.
United States1 site
Harbor Hospital, 3001 South Hanover Street, 7th Floor
Baltimore, Maryland, 21225
About this study
Official title: A Double-Blind, Placebo-Controlled, Randomized, Crossover Design Study With an Open-Label Active Control to Evaluate the Potential of Nestorone® to Delay Cardiac Repolarization in Healthy Female Volunteers: A Thorough QT/QTc Study
The purpose of the study is to evaluate the effect of Nestorone (NES) administered as an bolus injection on the corrected QT interval using Fridericia's formula (QTcF).
- Conditions
- Healthy
- Being tested
- Supratherapuetic dose of Nestorone, Placebo, Moxifloxacin
- Keywords
- Nestorone use as an IV solution on heart rate;, Abnormality in Heart Rate or Rhythm, Unspecified as to Time of Onset
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supratherapuetic dose of NestoroneDrug
PlaceboDrug
MoxifloxacinDrug
| Study group | Role | What they receive |
|---|---|---|
| Supratherapeutic dose of Nestorone | Experimental | Subjects will be randomized to a treatment sequence on Day 1 of Treatment Period 1, prior to administration of investigational product, according to a randomization schedule provided by the Sponsor Receives: Drug: Supratherapuetic dose of Nestorone |
| Placebo | Placebo comparator | Subjects will be randomized to a treatment sequence on Day 1 of Treatment Period 1, prior to administration of investigational product, according to a randomization schedule provided by the Sponsor Receives: Drug: Placebo |
| Moxifloxacin | Experimental | Subjects will be randomized to a treatment sequence on Day 1 of Treatment Period 1, prior to administration of investigational product, according to a randomization schedule provided by the Sponsor Receives: Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of Nestorone (NES) administered as an IV solution on the corrected QT interval using Fridericia's formula (QTcF).
Measurement of any changes from baseline in heart rhythm using an electrocardiogram at different time points after receiving NES as an IV solution
Measured: Days 1, 2, 30, 31, 32, and 33
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Council
- Sponsor type
- University, hospital or other
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- George W. Creasy, MD, Study director, Population Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02236026
- Sponsor's protocol ID
- 648
- Status last verified
- Aug 2017
- First submitted
- 28 Aug 2014
- Last updated
- 15 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Randomized, Crossover Design Study With an Open-Label Active Control to Evaluate the Potential of Nestorone® to Delay Cardiac Repolarization in Healthy Female Volunteers: A Thorough QT/QTc Study
- ClinicalTrials.gov ID
- NCT02236026
- Acronym / sponsor ID
- 648
- Conditions
- Healthy
- Keywords
- Nestorone use as an IV solution on heart rate;, Abnormality in Heart Rate or Rhythm, Unspecified as to Time of Onset
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Population CouncilUniversity, hospital or other
- Collaborators
- Parexel
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 Sep 2014 (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 purpose of the study is to evaluate the effect of Nestorone (NES) administered as an bolus injection on the corrected QT interval using Fridericia's formula (QTcF).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Supratherapeutic dose of Nestorone | Experimental | Drug: Supratherapuetic dose of NestoroneSubjects will be randomized to a treatment sequence on Day 1 of Treatment Period 1, prior to administration of investigational product, according to a randomization schedule provided by the Sponsor |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will be randomized to a treatment sequence on Day 1 of Treatment Period 1, prior to administration of investigational product, according to a randomization schedule provided by the Sponsor |
| Moxifloxacin | Experimental | Drug: MoxifloxacinSubjects will be randomized to a treatment sequence on Day 1 of Treatment Period 1, prior to administration of investigational product, according to a randomization schedule provided by the Sponsor |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Is a premenopausal female, ≥ 18 to < 40 years of age at the time of Screening;
- Has a BMI ≥ 18.5 and ≤ 32 kg/m2 (weight ≥ 50 kg) at Screening
- Is in a state of general good health based on medical history and physical examination;
- Is regularly menstruating (cycles of 22 to 35 days duration) over the previous 6 months prior to Screening, as reported by the subject;
- If of childbearing potential, must be practicing an acceptable non-hormonal, method of birth control until the end of the study (Exit/Early Termination). Such methods include but are not limited to: Sexual abstinence; Male or female condom in combination with spermicidal foam/gel/cream/ suppository; Vasectomized or female partner; Diaphragm/cervical cap with spermicide; Bilateral tubal ligation sterilization at least 6 months before the screening visit, or an ESSURE or ADIANA procedure with an hysterosalpingography confirmation test at least 6 months before the screening visit; Copper intrauterine device.
Key exclusion criteria (25 listed)
- Is pregnant or lactating;
- Has hypersensitivity or allergy to NES, moxifloxacin, or related compounds, or any of the inactive ingredients used in the investigational product formulations;
- Has a contraindication to progestin or estrogen therapy;
- Has impaired hypothalamic-pituitary-adrenal reserve, or history of oral glucocorticoid replacement therapy in 12 months prior to Screening.
- Has experienced undiagnosed genital bleeding, excluding inter-menstrual spotting, within 6 months of Screening;
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 |
|---|---|---|
| Supratherapuetic dose of Nestorone | Drug | Supratherapeutic dose of Nestorone |
| Placebo | Drug | Placebo |
| Moxifloxacin | Drug | Moxifloxacin |
Primary outcome
To evaluate the effect of Nestorone (NES) administered as an IV solution on the corrected QT interval using Fridericia's formula (QTcF).
Time frame: Days 1, 2, 30, 31, 32, and 33
Measurement of any changes from baseline in heart rhythm using an electrocardiogram at different time points after receiving NES as an IV solution
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2017.
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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.
George W. Creasy, MD study director
Population Council
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Supratherapuetic dose of Nestorone and Moxifloxacin in people with Healthy, run by Population Council at 1 site in United States.
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 6 inclusion and 25 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: finished, as of the sponsor's last update on 15 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evaluate the effect of Nestorone (NES) administered as an IV solution on the corrected QT interval using Fridericia's formula (QTcF). (time frame: Days 1, 2, 30, 31, 32, and 33). 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 15 Aug 2017.