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

NCT01809353 | Completed Phase 1

• 2 other identifiers: CR10098254452840HFA1001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Healthy; Japanese; Caucasian; Male; Pharmacokinetic; JNJ-54452840

Outcome Measures

Primary Outcomes (1)

• Serum concentrations of JNJ-54452840

  Serum concentrations of JNJ-54452840 will be used to determine pharmacokinetic parameters for JNJ-54452840

  Up to Day 2

Secondary Outcomes (1)

• Number of participants with an adverse event as a measure of safety

  Up to Day 2

Study Arms (8)

Group A: JNJ-54452840 20 mg

EXPERIMENTAL

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

Drug: JNJ-54452840

Group A: JNJ-54452840 80 mg

EXPERIMENTAL

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

Drug: JNJ-54452840

Group A: JNJ-54452840 240 mg

EXPERIMENTAL

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

Drug: JNJ-54452840

Group A: Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Group B: JNJ-54452840 20 mg

EXPERIMENTAL

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

Drug: JNJ-54452840

Group B: JNJ-54452840 80 mg

EXPERIMENTAL

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

Drug: JNJ-54452840

Group B: JNJ-54452840 240 mg

EXPERIMENTAL

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

Drug: JNJ-54452840

Group B: Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

JNJ-54452840 DRUG

Single intravenous (medication is injected into a vein) doses of 20 mg, 80 mg, and 240 mg

Group A: JNJ-54452840 20 mg; Group A: JNJ-54452840 240 mg; Group A: JNJ-54452840 80 mg; Group B: JNJ-54452840 20 mg; Group B: JNJ-54452840 240 mg; Group B: JNJ-54452840 80 mg

Placebo OTHER

Single matching intravenous dose

Group A: Placebo; Group B: Placebo

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Cypress, California, United States

Location

Related Links

• 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 Male Japanese and Caucasian Subjects

MeSH Terms

Interventions

JNJ-54452840

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

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: March 8, 2013
• First Posted: March 12, 2013
• Study Start: July 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 23, 2015

Record last verified: 2015-03

Locations

US (1)