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Cardiovascular monkey telemetry: sensitivity to detect QT interval prolongation.

A A Chaves1, W J Keller, S O'Sullivan

  • 1Safety Assessment, Merck Research Laboratories, P.O. Box 4, West Point, PA 19486, United States.

Journal of Pharmacological and Toxicological Methods
|May 9, 2006
PubMed
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This study demonstrates that a primate telemetry model reliably predicts QT interval prolongation, a key indicator of drug safety. This preclinical model effectively identifies potential pro-arrhythmia risks in novel human pharmaceuticals.

Area of Science:

  • Cardiovascular pharmacology
  • Preclinical drug safety assessment

Background:

  • Delayed ventricular repolarization, indicated by QT interval prolongation, is a critical preclinical safety marker for novel human pharmaceuticals.
  • Assessing the risk of pro-arrhythmia, such as Torsades de Pointes, is essential in drug development.
  • International Council for Harmonisation (ICH) S7A and S7B guidelines mandate preclinical evaluation of QT prolongation.

Purpose of the Study:

  • To evaluate the sensitivity and validity of the monkey telemetry model as a preclinical predictor of QT interval prolongation in humans.
  • To establish a reproducible and reliable preclinical model for assessing drug-induced QT prolongation.

Main Methods:

  • Cardiovascular monitoring in rhesus monkeys for 2 hours pre-dose and 24 hours post-dose.
  • Oral administration of Moxifloxacin (MOX) via gavage at escalating doses (0-175 mg/kg) in a 0.5% methylcellulose vehicle.

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  • Toxicokinetic evaluation and assessment of inherent model variability using vehicle control administration.

    • Main Results:

    • Moxifloxacin (MOX) showed no significant effects on mean arterial pressure, heart rate, PR, or QRS intervals.
    • MOX induced dose-related increases in corrected QT (QTc) intervals at doses of 30, 100, and 175 mg/kg.
    • Peak QTc increases ranged from 22 ms (8%) to 47 ms (18%) at the highest doses, demonstrating significant effects (p<0.05).

    Conclusions:

    • A reproducible, sensitive, and reliable primate telemetry model was developed in rhesus monkeys.
    • The model exhibits low inherent variability and high sensitivity to detect significant QT/QTc interval changes.
    • The primate telemetry model is a valuable preclinical tool for predicting QT prolongation of novel human pharmaceuticals.