Bioavailability and Pharmacokinetics Study of Sirukumab in Healthy Male Participants

Completed · Phase 1

Conditions studied: Healthy

In brief

The purpose of the study is to assess the bioavailability (the extent to which a medication becomes available to the body) of subcutaneously (under the skin using a needle) administered sirukumab and to compare the pharmacokinetics of sirukumab administered subcutaneously using a pre-filled syringe fitted with the UltraSafe Passive™ Delivery system (PFS-U) with the SmartJect™ Autoinjector (PFS-AI) in healthy male participants.

Key facts

Study ID

NCT02079545

Run by

Janssen Research & Development, LLC

People needed

144

Starts

2014-03-01

Expected to finish

2015-01-01

Last updated by the study team

2016-03-09

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Must have a weight in the range of 50.0 kg to 100.0 kg, inclusive
• Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram performed at screening
• Each participant must sign an informed consent form (ICF) indicating that he understands the purpose of and procedures required for the study and is willing to participate in the study
• Must be willing and able to adhere to the study visit schedule and other protocol requirements
• Must agree to abstain from alcohol intake 48 hours before administration of study agent and during the inpatient period of the study

You may not qualify if…

• Have any known malignancy or history of malignancy, except for nonmelanoma skin cancer that has been treated with no evidence of recurrence for at least 3 months before Day 1
• Have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly
• Have any underlying physical or psychological medical condition that, in the opinion of the investigator, would make it unlikely that the participant will complete the study
• Have evidence of any chronic medical condition requiring prescription medications (eg, hypertension, elevated cholesterol/triglycerides, asthma, or diabetes)
• Have a history of or current elevations in triglycerides that required treatment

Where it is running

• Study site — Tempe, Arizona, United States
• Study site — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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