A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-38431055 in Healthy Male Volunteers

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

This will be a single center study conducted in two parts. Part 1 will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of JNJ-38431055 in healthy male volunteers. Part 2 will assess the effect of food on the pharmacokinetics of JNJ-38431055.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Criteria

Inclusion Criteria:

• Body Mass Index (BMI) between 18.5 and 29.9 kg/m2 (inclusive)

• Healthy on the basis of physical examination including medical history, vital signs, 12-lead ECG, and all other screening lab tests performed

• Volunteers must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria:

• History of, or currently active, illness or medical condition or disorder that the Investigator considers to be clinically significant

• Smoker or tobacco user within the past 6 months

• History of recent major surgery (within 6 months of study start)

• Positive test for alcohol and/or drugs of abuse

• Psychological and/or emotional problems, which would render the informed consent invalid, or limit the ability of the volunteer to comply with the study requirements

• Any condition that, in the opinion of the investigator, would compromise the well being of the volunteer or the study or prevent the volunteer from meeting or performing study requirements.