To Assess the Pharmacokinetics and Safety of Single Doses of JNJ-54452840 in Healthy Japanese and Caucasian Participants
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT01809353
- Run by
- Janssen Research & Development, LLC
- People needed
- 32
- Starts
- 2013-07-01
- Expected to finish
- 2014-09-01
- Last updated by the study team
- 2015-03-23
Who can join
Age: 20 and older, up to 55. Sex: male. Healthy volunteers: accepted.
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
Where it is running
- Study site — Cypress, California, United States
Full record on ClinicalTrials.gov
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