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

Information source: Janssen Research & Development, LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Metoprolol tartrate immediate-release (metoprolol IR) (Drug); JNJ-54452840 (Drug); Placebo (Drug)

Phase: Phase 1

Status: Not yet recruiting

Sponsored by: Janssen Research & Development, LLC

Official(s) and/or principal investigator(s):
Janssen Research & Development, LLC Clinical Trial, Study Director, Affiliation: Janssen Research & Development, LLC

Overall contact:
This study is not yet recruiting patients. Please check back for future recruiting sites, or email, Email: JNJ.CT@sylogent.com

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Exercise Heart Rate

Exercise Heart Rate

Secondary outcome: Exercise Blood Pressure

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 5 weeks per participant. 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). 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.

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.

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

Locations and Contacts

This study is not yet recruiting patients. Please check back for future recruiting sites, or email, Email: JNJ.CT@sylogent.com

Additional Information

Starting date: July 2013
Last updated: July 15, 2013

Page last updated: August 23, 2015

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