Completed

A Phase 1 Randomized, Double-Blind, Placebo-Controlled Crossover Study to Evaluate the Pharmacokinetics and Safety of JNJ-54452840 Following Single Intravenous Doses to Healthy Japanese and Caucasian Subjects

What is being tested

JNJ-54452840

+ JNJ-54452840

DrugOther

Who is being recruted

From 20 to 55 Years

+6 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 1

Interventional

Study Start: July 2013

See protocol details

Summary

Principal SponsorJanssen Research & Development, LLC

Last updated: March 23, 2015

Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2013

Actual date on which the first participant was enrolled.

This is a Phase 1, randomized (the study treatment is assigned by chance), double-blind (neither physician nor participant knows the treatment received), placebo-controlled (one of the study treatments is inactive), four-way cross-over study (method used to switch participants from one treatment arm to another in a clinical trial) conducted in healthy male Japanese and Caucasian participants. The study will be conducted in 3 parts; a screening phase (up to 28 days), a double-blind treatment phase (28 days), and a follow-up phase (approximately 21 to 28 days). The study will be conducted in 2 groups (Group A consists of 16 Japanese participants; Group B consists of 16 Caucasian participants) over 4 treatment periods. On Day 1 of Period 1, approximately 16 eligible Japanese participants and the same number of eligible Caucasian participants will be randomly assigned to 1 of 4 treatment sequences and will receive the 4 intravenous treatments JNJ-54452840 20 mg, JNJ-54452840 80 mg, JNJ-54452840 240 mg, and placebo across the treatment periods according to the order specified by the randomization schedule. Participants will come to the study center each time they receive study medication and will be discharged from the study center 24 hours after dosing during each treatment period after satisfactory review of all clinical safety measures. Blood samples will be drawn at time points during the treatment and follow-up periods for participants in both Group A and Group B of the study. Participants will return to the study center for a follow-up visit within approximately 7 to 10 days after the last study procedure in the last treatment period for safety assessments, followed by another visit within approximately 21 to 28 days for assessment of anti -beta-1-AR (adrenergic receptor) auto-antibodies in blood (auto-antibodies targeting the human beta-1-AR antibody). If anti-beta-1-AR auto-antibodies are detected at this second follow-up visit, additional testing will be performed every 3 months until autoantibody levels fall below the level of detection of the assay or for 1 year, whichever occurs earlier. Participants in Group A and Group B will be involved in the study for approximately 12 weeks and up to 1 year if they develop anti -beta-1-AR auto-antibodies . Safety of the participants will be monitored throughout the study.

NCT01809353

Principal SponsorJanssen Research & Development, LLC

Last updated: March 23, 2015

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

32 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Male

Biological sex of participants that are eligible to enroll.

From 20 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

3 inclusion criteria required to participate

Caucasian participants must have Caucasian parents

Japanese participants must have been born in Japan, have resided outside of Japan for no more than 5 years, and have Japanese parents and maternal and paternal grandparents

Must be a healthy male with no clinically relevant abnormalities as determined by medical history, physical examination, blood chemistry assessments, hematologic assessments - Must be Japanese or Caucasian

3 exclusion criteria prevent from participating

Be unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins

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 protein

History of or current clinically significant medical illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

8 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Each participant will receive 20 mg of JNJ-54452840 as a single intravenous dose.

Group II

Experimental

Each participant will receive 80 mg of JNJ-54452840 as a single intravenous dose.

Group III

Experimental

Each participant will receive 240 mg of JNJ-54452840 as a single intravenous dose.

Group IV

Placebo

Each participant will receive matching placebo as a single intravenous dose.

Group 5

Experimental

Each participant will receive 20 mg of JNJ-54452840 as a single intravenous dose.

Group 6

Experimental

Each participant will receive 80 mg of JNJ-54452840 as a single intravenous dose.

Group 7

Experimental

Each participant will receive 240 mg of JNJ-54452840 as a single intravenous dose.

Group 8

Placebo

Each participant will receive matching placebo as a single intravenous dose.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Cypress, United StatesOpen in Google Maps

CompletedOne Study Center