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

Healthy research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Healthy

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Metoprolol tartrate immediate-release (metoprolol IR)Metoprolol IR will be administered as single oral dose of 100 mg tablet or capsule.

Drug:JNJ-54452840JNJ-54452840 (12 ml solution containing 240 mg JNJ-54452840) will be administered intravenously over 1 minute.

Drug:PlaceboMatching Placebo (normal saline) to JNJ-54452840 will be administered intravenously over 1 minute on Day 1.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Metoprolol plus placebo then Metoprolol plus JNJ-54452840Metoprolol tartrate immediate-release (metoprolol IR) will be administered as single oral dose of 100 milligram (mg) tablet or capsule. After two hours, placebo (normal saline) will be administered intravenously over 1 minute on Day 1.

Metoprolol plus JNJ-54452840 then Metoprolol plus placeboMetoprolol IR will be administered as single oral dose of 100 mg tablet or capsule. After two hours, JNJ-54452840 (12 milliliter [ml] solution containing 240 mg JNJ-54452840) will be administered intravenously over 1 minute.

Study Status

Withdrawn

Start Date: July 2013

Completed Date: May 2014

Phase: Phase 1

Type: Interventional

Design:

Primary Outcome: Exercise Heart Rate

Secondary Outcome: Exercise Blood Pressure

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor:

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01902550

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