A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-42721458 in Healthy Male Participants

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (what the body does to the medication), potential immunogenicity (ability to induce an immune response), and pharmacodynamics (what the drug does to the body) after administration of JNJ-42721458 in healthy adult male participants.

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

Details

• Lead Sponsor: Janssen Research & Development, LLC

Criteria

Inclusion Criteria:

• Body mass index (weight kg/m2) between 18 and 30 kg/m2, and body weight not less than 50 kg

• Participant is judged to be generally in good health based on medical history, physical examination, vital signs and laboratory safety tests

• Blood pressure between 90 and 135 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic

• A 12-lead electrocardiogram consistent with normal cardiac conduction and function

Exclusion Criteria:

• History of or current clinically significant medical illness

• Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or on Day -1 (at admission to the study center)

• Estimated creatinine clearance of less than or equal to 80 mL/min

• Clinically significant abnormal physical examination, vital signs or 12 lead electrocardiogram at screening or on Day -1

• Participant demonstrates orthostatic change in vital signs measurements on screening or predose while going from a semi recumbent to standing position

• History of significant multiple and/or severe allergies (including latex allergies) or known history of clinically significant allergies to polyethylene glycol (PEG) containing or other PEGylated products