A Crossover Study to Evaluate the Effect of JNJ-54452840 on Pharmacodynamics of Metoprolol Tartrate Immediate-Release in Healthy Participants

• Status: Withdrawn
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate effect of co-administration of JNJ-54452840 and metoprolol tartrate immediate-release (metoprolol IR) compared to metoprolol IR alone on the exercise heart rate and blood pressure measured at the end of each 3-minute exercise test in healthy participants.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Metoprolol

Criteria

Inclusion Criteria:

• Be a healthy non-smoking male with no clinically relevant abnormalities

• Able to perform upright bicycle ergometer exercise test and be able to achieve greater than or equal to 80 percent of maximum heart rate (HR) determined as (220 beats per minute [bpm]-age) during the last 10 seconds of the 3rd minute of exercise test

• Agree to abstain from caffeine (example, coffee, tea, chocolate, or caffeine-containing soft drinks) intake during the inpatient portion of the study

• Participants with body mass index between 18 and 32 kilogram per square meter (kg/m^2) and body weight greater than or equal to 50 kilogram (Kg) at screening

Exclusion Criteria:

• Contraindication to metoprolol tartrate immediate release (metoprolol IR)

• Resting HR less than 50 bpm and blood pressure less than 110/70 millimeter of mercury (mmHg)

• Physical disability that would preclude safe and adequate exercise test performance

• History of or current clinically significant medical illness that the Investigator considers should exclude the subject or that could interfere with the interpretation of the study results

• Determined to have variant cytochrome P4502D6 (CYP2D6) alleles encoding for altered metabolism

• Have a known or suspected intolerance or hypersensitivity to any biologic medication or known allergies or clinically significant reactions to murine, chimeric, or human peptides or proteins