MedDataX Logo

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

NCT ID: NCT01902550

Last Updated: 2016-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Healthy JNJ-54452840 Metoprolol Tartrate Immediate-Release Placebo Male

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Metoprolol tartrate immediate-release (metoprolol IR)

Intervention Type DRUG

Metoprolol IR will be administered as single oral dose of 100 mg tablet or capsule.

JNJ-54452840

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Metoprolol tartrate immediate-release (metoprolol IR)

Intervention Type DRUG

Metoprolol IR will be administered as single oral dose of 100 mg tablet or capsule.

JNJ-54452840

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Metoprolol tartrate immediate-release (metoprolol IR)

Metoprolol IR will be administered as single oral dose of 100 mg tablet or capsule.

Intervention Type DRUG

JNJ-54452840

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Knoxville, Tennessee, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

54452840HFA1002

Identifier Type: -

Identifier Source: secondary_id

CR102301

Identifier Type: -

Identifier Source: org_study_id