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

NCT02616913 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2015-11-30

No results posted yet for this study

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

Interventions

OTHER

R,R-monatin

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

OTHER

Moxifloxacin

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

OTHER

Placebo

Each subject consumes placebo in one of 3 treatment periods

Sponsors & Collaborators

  • Ajinomoto Co., Inc.

    collaborator INDUSTRY

  • Cargill

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2013-06-30
Completion
2013-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02616913 on ClinicalTrials.gov