NCT01902550

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2013

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 18, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

3 months

First QC Date

July 15, 2013

Last Update Submit

October 31, 2016

Conditions

Healthy

Keywords

HealthyJNJ-54452840Metoprolol Tartrate Immediate-ReleasePlaceboMale

Outcome Measures

Primary Outcomes (2)

  • Exercise Heart Rate

    Heart rate will be measured during the last 10 seconds of each 3-minute upright bicycle ergometer exercise test in healthy participants.

    Day 1 of Treatment Period 1

  • Exercise Heart Rate

    Heart rate will be measured during the last 10 seconds of each 3-minute upright bicycle ergometer exercise test in healthy participants.

    Day 1 of Treatment Period 2

Secondary Outcomes (1)

  • Exercise Blood Pressure

    Day 1 of Treatment Period 1 and 2

Study Arms (2)

Metoprolol plus placebo then Metoprolol plus JNJ-54452840

EXPERIMENTAL

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)Drug: JNJ-54452840Drug: Placebo

Metoprolol plus JNJ-54452840 then Metoprolol plus placebo

EXPERIMENTAL

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)Drug: JNJ-54452840Drug: Placebo

Interventions

Metoprolol tartrate immediate-release (metoprolol IR)DRUG

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

Metoprolol plus JNJ-54452840 then Metoprolol plus placeboMetoprolol plus placebo then Metoprolol plus JNJ-54452840
JNJ-54452840DRUG

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

Metoprolol plus JNJ-54452840 then Metoprolol plus placeboMetoprolol plus placebo then Metoprolol plus JNJ-54452840
PlaceboDRUG

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

Metoprolol plus JNJ-54452840 then Metoprolol plus placeboMetoprolol plus placebo then Metoprolol plus JNJ-54452840

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Knoxville, Tennessee, United States

Location

MeSH Terms

Interventions

JNJ-54452840

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2013

First Posted

July 18, 2013

Study Start

July 1, 2013

Primary Completion

October 1, 2013

Study Completion

May 1, 2014

Last Updated

November 1, 2016

Record last verified: 2016-10

Locations

US(1)