A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-39439335 in Healthy Japanese and Caucasian Adult Male Participants

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of JNJ-39439335 in healthy Japanese and Caucasian adult male participants in Part 1, and in healthy Japanese adult male participants in Part 2.

Key facts

Study ID

NCT01631487

Run by

Janssen Research & Development, LLC

People needed

86

Starts

2012-07-01

Expected to finish

2013-03-01

Last updated by the study team

2013-06-25

Who can join

Age: 20 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Japanese or Caucasian participants
• Nonsmoker
• Body Mass Index (BMI) of 18 to 30 kg/m2, inclusive, and body weight not less than 50 kg
• Healthy on the basis of a physical examination, vital signs, hematology, coagulation, serum chemistry (including liver function tests) and urinalysis
• Willing to adhere to the prohibitions and restrictions specified by the study protocol

You may not qualify if…

• Oral temperatures > 37.5 Celsius degrees
• Participants who have occupations or hobbies in which they are routinely exposed to situations in which they could sustain thermal burns
• Abnormal electrocardiogram (ECG) results
• Clinically significant abnormal values for hematology, clinical chemistry or urinalysis
• 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

Where it is running

• Study site — Cypress, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.