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Cardiorespiratory safety evaluation in non-human primates.

Jennifer L Ingram-Ross1, Aidan K Curran, Mutsumi Miyamoto

  • 1Janssen Research and Development, LLC, Raritan, NJ, USA.

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|April 24, 2012
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Respiratory inductance plethysmography (RIP) offers a reliable method for assessing drug effects on respiration in non-human primates (NHP). This integrated cardiorespiratory safety assessment demonstrates the feasibility of continuous monitoring during nonclinical drug development.

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Area of Science:

  • Pharmacology
  • Cardiovascular Safety
  • Respiratory Safety

Background:

  • Nonclinical safety pharmacology studies are crucial for drug development.
  • Assessing respiratory function alongside cardiovascular function provides a more comprehensive safety profile.
  • Non-human primates (NHP) are often used models for cardiorespiratory safety assessments.

Purpose of the Study:

  • To evaluate the utility of respiratory inductance plethysmography (RIP) for nonclinical respiratory safety pharmacology.
  • To integrate respiratory and cardiovascular safety assessments in a single study using NHP.
  • To determine the most appropriate RIP calibration method for NHP.

Main Methods:

  • Respiratory inductance plethysmography (RIP) was calibrated in conscious and anesthetized NHP.
  • Calibration accuracy was confirmed using a CO(2) rebreathe maneuver.
  • Cardiovascular (telemetry) and respiratory (RIP) parameters were monitored in NHP following single and repeated doses of a test article.

Main Results:

  • The RIP system accurately assessed CO(2) rebreathe responses.
  • A test article caused transient increases and subsequent decreases in heart rate, blood pressure, and respiratory parameters.
  • Slight QTcR prolongation was observed after a single high dose of the test article.

Conclusions:

  • Integrated cardiorespiratory assessment in NHP is feasible for at least 24 hours postdose.
  • Respiratory inductance plethysmography (RIP) complements cardiovascular assessments without interference.
  • This integrated approach enhances the safety evaluation of novel compounds.