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

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ClinicalTrials.gov Identifier: NCT01902550
Recruitment Status : Withdrawn (Trial was stopped because study not required for development.)
First Posted : July 18, 2013
Last Update Posted : November 1, 2016
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Metoprolol tartrate immediate-release (metoprolol IR) Drug: JNJ-54452840 Drug: Placebo Phase 1

Detailed Description:
This is a Phase 1, randomized (the study drug is assigned by chance), single-center, double-blind (neither physician nor participant knows the treatment that the participant receives) and 2-period crossover (participants may receive different interventions sequentially during the trial) study of JNJ-54452840 and metoprolol tartrate in healthy participants. The duration of study will be up to 7 weeks per participant and up to 1 year for participants if they develop anti-beta 1-AR (adrenergic receptor) auto-antibodies (auto-antibodies targeting the human beta-1-AR, antibody is a type of protein that helps protect the body against foreign matter, such as bacteria and viruses). The study consists of 3 parts: Screening (that is, up to 14 days before study commences on Day 1); Treatment (consists of either metoprolol IR and JNJ-54452840 or metoprolol IR and Placebo for 8 days, in subsequent two-treatment periods, separated by wash-out period of 2-7 days); and Follow-up (that is, 7-10 days after last study dose for safety assessment; followed by another visit after 21-28 days of last study dose for assessment of anti beta-1-AR auto-antibodies in blood). Any potential interaction between JNJ-54452840 and metoprolol tartrate IR will primarily be evaluated by measuring exercise induced heart rate (that is, post exercise). Participants' safety will be monitored throughout the study. If beta-1-AR-auto-antibodies are detected at the follow up visit 21-28 days after last treatment period study procedure, additional testing will be performed every 3 months until auto-antibody levels fall below the level of detection of the assay or for 1 year, whichever occurs earlier.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, 2-Period Crossover Study to Evaluate the Effect of Single Dose JNJ-54452840 on Pharmacodynamics of Metoprolol Tartrate Immediate-Release in Healthy Subjects
Study Start Date : July 2013
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Metoprolol plus placebo then Metoprolol plus JNJ-54452840
Metoprolol 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.
Drug: Metoprolol tartrate immediate-release (metoprolol IR)
Metoprolol IR will be administered as single oral dose of 100 mg tablet or capsule.

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

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

Experimental: Metoprolol plus JNJ-54452840 then Metoprolol plus placebo
Metoprolol 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.
Drug: Metoprolol tartrate immediate-release (metoprolol IR)
Metoprolol IR will be administered as single oral dose of 100 mg tablet or capsule.

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

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




Primary Outcome Measures :
  1. Exercise Heart Rate [ Time Frame: Day 1 of Treatment Period 1 ]
    Heart rate will be measured during the last 10 seconds of each 3-minute upright bicycle ergometer exercise test in healthy participants.

  2. Exercise Heart Rate [ Time Frame: Day 1 of Treatment Period 2 ]
    Heart rate will be measured during the last 10 seconds of each 3-minute upright bicycle ergometer exercise test in healthy participants.


Secondary Outcome Measures :
  1. Exercise Blood Pressure [ Time Frame: Day 1 of Treatment Period 1 and 2 ]
    Blood Pressure will be measured during the last 10 seconds of each 3-minute upright bicycle ergometer exercise test in healthy participants.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01902550


Locations
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United States, Tennessee
Knoxville, Tennessee, United States
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01902550     History of Changes
Other Study ID Numbers: CR102301
54452840HFA1002
First Posted: July 18, 2013    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016

Keywords provided by Janssen Research & Development, LLC:
Healthy
JNJ-54452840
Metoprolol Tartrate Immediate-Release
Placebo
Male

Additional relevant MeSH terms:
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Metoprolol
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action