Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02616913
Other study ID # 8280290
Secondary ID
Status Completed
Phase N/A
First received November 5, 2015
Last updated November 25, 2015
Start date March 2013
Est. completion date October 2013

Study information

Verified date November 2015
Source Cargill
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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). Each subject will consume test article (150 mg), placebo, and moxifloxacin (400 mg; positive control) in each of 3 treatment periods.


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).


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date October 2013
Est. primary completion date June 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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;

- 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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)


Related Conditions & MeSH terms


Intervention

Other:
R,R-monatin
Each subject consumes test article R,R-monatin (150 mg) in one of 3 treatment periods
Moxifloxacin
Each subject consumes moxifloxacin (400 mg; positive control) in one of 3 treatment periods
Placebo
Each subject consumes placebo in one of 3 treatment periods

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Cargill Ajinomoto Co., Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary Fridericia-corrected QT ECG interval (QTcF) 24 hours Yes
Secondary Electrocardiogram parameters: Heart rate, PR interval, QRS and T-wave morphology 24 hours Yes
See also
  Status Clinical Trial Phase
Suspended NCT05542238 - The Effect of Acute Exercise on Cardiac Autonomic, Cerebrovascular, and Cognitive Function in Spinal Cord Injury N/A
Active, not recruiting NCT02973126 - Heartflow (AFFECTS) Phase 3
Completed NCT01410487 - Effects of Weight Loss on Cardio-respiratory Function N/A
Withdrawn NCT00844935 - Electrocardiographic Autonomic Function Measures in Mechanically Ventilated Patients N/A
Withdrawn NCT00807274 - Renal Function in Adults With Congenital Heart Disease. N/A
Withdrawn NCT00468702 - Postoperative Canadian Oral Anticoagulation Self-management (Post-COAGS) Trial N/A
Completed NCT04340388 - Contribution of Dolutegravir to Obesity and Cardiovascular Disease Phase 4
Completed NCT03545672 - Early Identification of Myocardial Impairment in PBC
Completed NCT03758092 - Cardiovascular Screening in Infants Born Small for Gestational Age
Recruiting NCT06091384 - Inspiratory Muscle Strength Training in Post-Covid Syndrome N/A
Completed NCT04586894 - Adverse Myocardial and Vascular Side Effects of Immune Checkpoint Inhibitors
Completed NCT03826914 - The Effects of the Dietary Supplement CardioFlex Q10 on Reducing Cardiovascular Disease Risk Factors in Adults N/A
Not yet recruiting NCT05624255 - Correlating the Measure of Retinal Vascular Density Through Angio-OCT With Calcium Score N/A
Completed NCT02966028 - Effect of SNF472 on Progression of Cardiovascular Calcification in End-Stage-Renal-Disease (ESRD) Patients on Hemodialysis (HD) Phase 2
Completed NCT01820702 - Short Term Bed Rest Study: Evaluation of the Use of Artificial Gravity, Induced by Short-arm Centrifugation N/A
Recruiting NCT04766203 - Relative Energy Deficiency in Sport Multicenter Study N/A
Completed NCT01811667 - Efficacy and Safety of the Mammalian Target of Rapamycin (mTor Rapamycin) Inhibitor in Vascular Malformations Phase 3
Terminated NCT02351726 - Mitroflow DL Post Approval Study- North America N/A
Completed NCT00901394 - Vitamin B12 and Folate Administration on Homocysteine Concentrations After Nitrous Oxide Anesthesia N/A
Completed NCT03354689 - Transcutaneous Electrical Nerve Stimulation and Cardiac Sympathetic Overdrive in Heart Failure