To Assess the Pharmacokinetics and Safety of Single Doses of JNJ-54452840 in Healthy Japanese and Caucasian Participants
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 20 - 55 |
Updated: | 11/30/2013 |
Start Date: | July 2013 |
End Date: | August 2013 |
Contact: | This study is not yet recruiting patients. Please check back for future recruiting sites, or email |
Email: | JNJ.CT@sylogent.com |
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
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.
This will be a randomized (the study treatment is assigned by chance), double-blind (neither
investigator nor patient 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 phases; a screening phase, a
double-blind treatment phase, and a follow-up phase. 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 follow-up visits within
approximately 7 to 10 days after the last study procedure in the last treatment period, for
final follow-up safety assessments. Participants in Group A and Group B will be involved in
the study for approximately 10 weeks. Safety of the participants will be monitored.
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
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