Evaluation of the Cardiac Effects of a Novel Food Ingredient in Healthy Male Subjects

NCT02616913 | Completed DMC

• 1 other identifier: 8280290
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cardiovascular Abnormalities

Outcome Measures

Primary Outcomes (1)

• Fridericia-corrected QT ECG interval (QTcF)

  24 hours

Secondary Outcomes (1)

• Electrocardiogram parameters: Heart rate, PR interval, QRS and T-wave morphology

  24 hours

Study Arms (3)

R,R-monatin

EXPERIMENTAL

150 mg single dose

Other: R,R-monatin

Moxifloxacin

ACTIVE COMPARATOR

400 mg tablet single dose

Other: Moxifloxacin

Placebo

PLACEBO COMPARATOR

placebo single dose

Other: Placebo

Interventions

R,R-monatin OTHER

Each subject consumes test article R,R-monatin (150 mg) in one of 3 treatment periods

R,R-monatin

Moxifloxacin OTHER

Each subject consumes moxifloxacin (400 mg; positive control) in one of 3 treatment periods

Moxifloxacin

Placebo OTHER

Each subject consumes placebo in one of 3 treatment periods

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Cargill: lead
• Ajinomoto Co., Inc.: collaborator

MeSH Terms

Conditions

Cardiovascular Abnormalities

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2015
• First Posted: November 30, 2015
• Study Start: March 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: October 1, 2013
• Last Updated: November 30, 2015

Record last verified: 2015-11