Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

To Assess the Pharmacokinetics and Safety of Single Doses of JNJ-54452840 in Healthy Japanese and Caucasian Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01809353
Recruitment Status : Completed
First Posted : March 12, 2013
Last Update Posted : March 23, 2015
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the drug) and safety of JNJ-54452840 in healthy participants.

Condition or disease Intervention/treatment Phase
Healthy Drug: JNJ-54452840 Other: Placebo Phase 1

Detailed Description:

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Arm Intervention/treatment
Experimental: Group A: JNJ-54452840 20 mg
Each participant will receive 20 mg of JNJ-54452840 as a single intravenous dose.
Drug: JNJ-54452840
Single intravenous (medication is injected into a vein) doses of 20 mg, 80 mg, and 240 mg

Experimental: Group A: JNJ-54452840 80 mg
Each participant will receive 80 mg of JNJ-54452840 as a single intravenous dose.
Drug: JNJ-54452840
Single intravenous (medication is injected into a vein) doses of 20 mg, 80 mg, and 240 mg

Experimental: Group A: JNJ-54452840 240 mg
Each participant will receive 240 mg of JNJ-54452840 as a single intravenous dose.
Drug: JNJ-54452840
Single intravenous (medication is injected into a vein) doses of 20 mg, 80 mg, and 240 mg

Placebo Comparator: Group A: Placebo
Each participant will receive matching placebo as a single intravenous dose.
Other: Placebo
Single matching intravenous dose

Experimental: Group B: JNJ-54452840 20 mg
Each participant will receive 20 mg of JNJ-54452840 as a single intravenous dose.
Drug: JNJ-54452840
Single intravenous (medication is injected into a vein) doses of 20 mg, 80 mg, and 240 mg

Experimental: Group B: JNJ-54452840 80 mg
Each participant will receive 80 mg of JNJ-54452840 as a single intravenous dose.
Drug: JNJ-54452840
Single intravenous (medication is injected into a vein) doses of 20 mg, 80 mg, and 240 mg

Experimental: Group B: JNJ-54452840 240 mg
Each participant will receive 240 mg of JNJ-54452840 as a single intravenous dose.
Drug: JNJ-54452840
Single intravenous (medication is injected into a vein) doses of 20 mg, 80 mg, and 240 mg

Placebo Comparator: Group B: Placebo
Each participant will receive matching placebo as a single intravenous dose.
Other: Placebo
Single matching intravenous dose




Primary Outcome Measures :
  1. Serum concentrations of JNJ-54452840 [ Time Frame: Up to Day 2 ]
    Serum concentrations of JNJ-54452840 will be used to determine pharmacokinetic parameters for JNJ-54452840


Secondary Outcome Measures :
  1. Number of participants with an adverse event as a measure of safety [ Time Frame: Up to Day 2 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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
  • 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
  • Caucasian participants must have Caucasian parents

Exclusion Criteria:

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

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): NCT01809353


Locations
Layout table for location information
United States, California
Cypress, California, United States
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Layout table for investigator information
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Additional Information:
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01809353     History of Changes
Other Study ID Numbers: CR100982
54452840HFA1001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: March 12, 2013    Key Record Dates
Last Update Posted: March 23, 2015
Last Verified: March 2015

Keywords provided by Janssen Research & Development, LLC:
Healthy
Japanese
Caucasian
Male
Pharmacokinetic
JNJ-54452840