Cardiovascular AbnormalitiesNCT02616913
Evaluation of the Cardiac Effects of a Novel Food Ingredient in Healthy Male Subjects
A study testing R,R-monatin and Moxifloxacin in people with Cardiovascular Abnormalities, run by Cargill.
Trial summary
This study evaluates if a single oral dose of 150 mg of the novel food ingredient (AME001, R,R-monatin) does not have an effect on the Fridericia-corrected QT ECG interval (QTcF) exceeding 10 milliseconds (msec). Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Abnormalities
- What is being tested?
- R,R-monatin and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Oct 2013
- Phase
- Interventional
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smoking healthy male between 18 and 45 years of age;
- BMI within the range 18.0 to 30.0 kg/m2, inclusive, and with a body weight ≥60 kg;
- Subjects with a partner of childbearing potential agree to use dual methods of contraception from Check-in until 3 months (90 days) after the last treatment, and to provide no sperm donation from Check-in until 3 months (90 days) after last administration of test article. Double barrier methods include: a male condom with spermicide; a sterile sexual partner; use by female sexual partner of an intrauterine device (IUD) with spermicide; a female condom with spermicide; contraceptive sponge with spermicide; an intravaginal system (e.g. NuvaRing®) a diaphragm with spermicide; a cervical cap with spermicide; or oral, implantable, transdermal, or injectable contraceptives;
- Subjects must be in good health, determined by no clinically significant or relative abnormalities identified by medical history, full physical examination, vital signs measurements, 12-lead ECG, and clinical laboratory evaluations;
- Subjects must be willing and able to comply with all study requirements;
- Subjects must have given written informed consent.
Who cannot join
- Presence of history of any disorder that may prevent successful completion of the study, in the opinion of the investigator;
- Subjects who have received an investigational product (investigational pharmaceutical or a medical device) within the 30 days prior to Day -1 of the first treatment period (Check-in);
- Any cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease that are clinically significant in the opinion of the Investigator;
- Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of test article (cholecystectomy and appendectomy allowed);
- Any acute disease state (e.g. nausea, vomiting, fever, or diarrhea) within 7 days before Day -1 of the first treatment period (Check-in);
- History of drug abuse within 1 year before Day -1 of the first treatment period, as assessed by the Investigator, where drug abuse is defined as: recurrent use of a substance resulting in failure to fulfill a person's major role obligation at work or at home; recurrent use in physically hazardous situations; recurrent substance-related legal problems; or continued use despite persistent or recurrent social or interpersonal problems caused or exacerbated by the substance;
Show all 17Show fewer
- Admitted alcohol abuse or history of alcohol use that may interfere with the subject's ability to comply with the protocol requirements in the opinion of the Investigator;
- Family history of Long QT Syndrome and/or unexplained sudden cardiac death;
- Any clinically important deviation from normal limits in physical examination, vital signs, 12-lead ECG, or clinical laboratory test results, in the opinion of the Investigator;
- Electrolyte results for Ca, Mg, and K outside of normal limits; all other electrolytes will be assessed by the Investigator for clinical significance and subjects will be excluded if results are deemed clinically significant;
- QTc duration ≥450 msec based on machine-read tracing at Screening. Recalculation into QTcF and up to 1 repeat may be allowed; further repeats may be allowed if discussed and agreed with the Medical Monitor;
- Positive serologic findings for HIV antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies;
- Positive findings on urine drug screen (e.g. amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates);
- History of any clinically important allergy to moxifloxacin;
- History of any significant adverse drug reaction to any fluoroquinolone;
- Use of any investigational medications within 30 days prior to the first dose and the use of any prescription medications during the interval from 14 days prior to Check-in for the first treatment period until after the completion of the study. In addition, subjects will refrain from the use of any over-the-counter non-prescription medications (including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations; except for the occasional use of acetaminophen), and all dietary supplements, within 7 days before Day -1 of the first treatment period (Check-in);
- Consumption of any caffeine-containing products (e.g. coffee, tea, chocolate, or soda) or alcoholic beverages within 72 hours before Day -1 of the first treatment period (Check-in).
About this study
Official title: A Single Dose, Double Blind, Randomized, Crossover Placebo- and Moxifloxacin (Open Label)-Controlled Study to Evaluate the Cardiac Effects of a Novel Food Ingredient in Healthy Male Subjects
This study evaluates if a single oral dose of 150 mg of the novel food ingredient (AME001, R,R-monatin) does not have an effect on the Fridericia-corrected QT ECG interval (QTcF) exceeding 10 milliseconds (msec). Each subject will consume test article (150 mg), placebo, and moxifloxacin (400 mg; positive control) in each of 3 treatment periods.
Read the detailed description
This study is specifically designed to evaluate the potential effects of ingestion of the novel food ingredient on cardiac safety. The objective will be fulfilled by assessing cardiac parameters including heart rate, blood pressure, and ECG/QT interval in healthy adult male subjects following a single dose oral administration of the test article.
The primary objective of this study is to demonstrate that a single oral dose of 150 mg of the test article does not have an effect on the Fridericia-corrected QT ECG interval (QTcF) exceeding 10 milliseconds (msec).
- Conditions
- Cardiovascular Abnormalities
- Being tested
- R,R-monatin, Moxifloxacin, Placebo
- Medical subject headings
- Cardiovascular Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R,R-monatinOther
Each subject consumes test article R,R-monatin (150 mg) in one of 3 treatment periods
MoxifloxacinOther
Each subject consumes moxifloxacin (400 mg; positive control) in one of 3 treatment periods
PlaceboOther
Each subject consumes placebo in one of 3 treatment periods
| Study group | Role | What they receive |
|---|---|---|
| R,R-monatin | Experimental | 150 mg single dose Receives: Other: R,R-monatin |
| Moxifloxacin | Active comparator | 400 mg tablet single dose Receives: Other: Moxifloxacin |
| Placebo | Placebo comparator | placebo single dose Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fridericia-corrected QT ECG interval (QTcF)
Measured: 24 hours
Secondary outcomes (1)
Electrocardiogram parameters: Heart rate, PR interval, QRS and T-wave morphology
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2015 (estimated)
- Study startMar 2013
- Primary completionJun 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular AbnormalitiesStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cargill
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ajinomoto Co., Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02616913
- Sponsor's protocol ID
- 8280290
- Status last verified
- Nov 2015
- First submitted
- 5 Nov 2015
- Last updated
- 30 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose, Double Blind, Randomized, Crossover Placebo- and Moxifloxacin (Open Label)-Controlled Study to Evaluate the Cardiac Effects of a Novel Food Ingredient in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02616913
- Acronym / sponsor ID
- 8280290
- Conditions
- Cardiovascular Abnormalities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- CargillIndustry (pharma, biotech, devices)
- Collaborators
- Ajinomoto Co., Inc.
- Study start
- Mar 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 30 Nov 2015 (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.
This study evaluates if a single oral dose of 150 mg of the novel food ingredient (AME001, R,R-monatin) does not have an effect on the Fridericia-corrected QT ECG interval (QTcF) exceeding 10 milliseconds (msec). Each subject will consume test article (150 mg), placebo, and moxifloxacin (400 mg; positive control) in each of 3 treatment periods.
Detailed description
This study is specifically designed to evaluate the potential effects of ingestion of the novel food ingredient on cardiac safety. The objective will be fulfilled by assessing cardiac parameters including heart rate, blood pressure, and ECG/QT interval in healthy adult male subjects following a single dose oral administration of the test article.
The primary objective of this study is to demonstrate that a single oral dose of 150 mg of the test article does not have an effect on the Fridericia-corrected QT ECG interval (QTcF) exceeding 10 milliseconds (msec).
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| R,R-monatin | Experimental | Other: R,R-monatin150 mg single dose |
| Moxifloxacin | Active comparator | Other: Moxifloxacin400 mg tablet single dose |
| Placebo | Placebo comparator | Other: Placeboplacebo single dose |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Non-smoking healthy male between 18 and 45 years of age;
- BMI within the range 18.0 to 30.0 kg/m2, inclusive, and with a body weight ≥60 kg;
- Subjects with a partner of childbearing potential agree to use dual methods of contraception from Check-in until 3 months (90 days) after the last treatment, and to provide no sperm donation from Check-in until 3 months (90 days) after last administration of test article. Double barrier methods include: a male condom with spermicide; a sterile sexual partner; use by female sexual partner of an intrauterine device (IUD) with spermicide; a female condom with spermicide; contraceptive sponge with spermicide; an intravaginal system (e.g. NuvaRing®) a diaphragm with spermicide; a cervical cap with spermicide; or oral, implantable, transdermal, or injectable contraceptives;
- Subjects must be in good health, determined by no clinically significant or relative abnormalities identified by medical history, full physical examination, vital signs measurements, 12-lead ECG, and clinical laboratory evaluations;
- Subjects must be willing and able to comply with all study requirements;
Key exclusion criteria (17 listed)
- Presence of history of any disorder that may prevent successful completion of the study, in the opinion of the investigator;
- Subjects who have received an investigational product (investigational pharmaceutical or a medical device) within the 30 days prior to Day -1 of the first treatment period (Check-in);
- Any cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease that are clinically significant in the opinion of the Investigator;
- Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of test article (cholecystectomy and appendectomy allowed);
- Any acute disease state (e.g. nausea, vomiting, fever, or diarrhea) within 7 days before Day -1 of the first treatment period (Check-in);
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 |
|---|---|---|
| R,R-monatinEach subject consumes test article R,R-monatin (150 mg) in one of 3 treatment periods | Other | R,R-monatin |
| MoxifloxacinEach subject consumes moxifloxacin (400 mg; positive control) in one of 3 treatment periods | Other | Moxifloxacin |
| PlaceboEach subject consumes placebo in one of 3 treatment periods | Other | Placebo |
Primary outcome
Fridericia-corrected QT ECG interval (QTcF)
Time frame: 24 hours
1 secondary outcome
Electrocardiogram parameters: Heart rate, PR interval, QRS and T-wave morphology
Time frame: 24 hours
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 30 Nov 2015.
Related trials for Cardiovascular Abnormalities
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
Not yet recruitingPhase 1
Topical TOR-582 Treatment of Epistaxis in HHT
Hereditary Hemorrhagic Telangiectasia (HHT), Epistaxis
RecruitingPhase 1/2
Harmony-HHT: ATV-1601 in Participants With Hereditary Hemorrhagic Telangiectasia (HHT)
Hereditary Hemorrhagic Telangiectasia (HHT), Osler Weber Rendu Disease
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
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 study testing R,R-monatin and Moxifloxacin in people with Cardiovascular Abnormalities, run by Cargill.
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 17 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 30 Nov 2015. 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. 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.
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?
Fridericia-corrected QT ECG interval (QTcF) (time frame: 24 hours). 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 30 Nov 2015.