Bioavailability and Pharmacokinetics Study of Sirukumab in Healthy Male Participants

NCT ID: NCT02079545

Last Updated: 2016-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-01-31

Brief Summary

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.

Detailed Description

This is a randomized (the study medication is assigned by chance), open-label (all people know the identity of the intervention), parallel-group (each group of participants will be treated at the same time), multicenter; single-dose study. Approximately 138 participants will be randomly allocated in a 3:3:3:7:7 ratio to 1 of the 5 treatment groups as follows: Group 1 (a single intravenous infusion of 100 mg sirukumab), Group 2 (a single subcutaneous [SC] injection of 50 mg sirukumab with PFS-U), Group 3 (a single SC injection of 50 mg sirukumab with PFS-AI, Group 4 (a single SC injection of 100 mg sirukumab with PFS-U), and Group 5 (a single SC injection of 100 mg sirukumab with PFS-AI). Randomization will be stratified by body weight (50.0 kg to <70.0 kg, 70.0 kg to <85.0 kg, 85.0 kg to 100.0 kg). Participants will be hospitalized in the study unit for administration of study drug and will be discharged after completion of all scheduled assessments on Day 5. Participants will be required to return to the study unit for outpatient visits on Days 6 and 7, followed by weekly/biweekly outpatient visits, and then a safety follow-up for a total of 13 weeks after study drug administration. Safety evaluations will include assessment of adverse events, physical examination, vital signs, injection site and infusion reactions, electrocardiogram, and clinical laboratory tests. The maximum study duration for each participant will be 120 days.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Group 1

18 participants will receive a single intravenous (IV) infusion of 100 mg sirukumab

Group Type: EXPERIMENTAL

Sirukumab (IV infusion)

Intervention Type: DRUG

Participants will receive a single IV infusion of 100 mg sirukumab.

Group 2

18 participants will receive a single subcutaneous (SC) injection of 50 mg sirukumab using a Pre-filled Syringe (PFS) fitted with the UltraSafe Passive™ Delivery System (PFS-U)

Group Type: EXPERIMENTAL

Sirukumab (SC injection with PFS-U)

Intervention Type: DRUG

Participants will receive a single SC injection of 50 mg sirukumab with PFS-U.

Group 3

18 participants will receive a single SC injection of 50 mg sirukumab using the SmartJect™ Autoinjector (PFS-AI)

Group Type: EXPERIMENTAL

Sirukumab (SC injection with PFS-AI)

Intervention Type: DRUG

Participants will receive a single SC injection of 50 mg sirukumab with PFS-AI.

Group 4

42 participants will receive a single SC injection of 100 mg sirukumab using a PFS-U

Group Type: EXPERIMENTAL

Sirukumab (SC injection with PFS-U)

Intervention Type: DRUG

Participants will receive a single SC injection of 100 mg sirukumab with PFS-U.

Group 5

42 participants will receive a single SC injection of 100 mg sirukumab using a PFS-AI

Group Type: EXPERIMENTAL

Sirukumab (SC injection with PFS-AI)

Intervention Type: DRUG

Participants will receive a single SC injection of 100 mg sirukumab with PFS-AI.

Interventions

Sirukumab (IV infusion)

Participants will receive a single IV infusion of 100 mg sirukumab.

Intervention Type: DRUG

Sirukumab (SC injection with PFS-U)

Participants will receive a single SC injection of 50 mg sirukumab with PFS-U.

Intervention Type: DRUG

Sirukumab (SC injection with PFS-AI)

Participants will receive a single SC injection of 50 mg sirukumab with PFS-AI.

Intervention Type: DRUG

Sirukumab (SC injection with PFS-U)

Participants will receive a single SC injection of 100 mg sirukumab with PFS-U.

Intervention Type: DRUG

Sirukumab (SC injection with PFS-AI)

Participants will receive a single SC injection of 100 mg sirukumab with PFS-AI.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Tempe, Arizona, United States

Lincoln, Nebraska, United States

Countries

United States

Other Identifiers

CNTO136NAP1003

Identifier Type: OTHER

Identifier Source: secondary_id

CR103367

Identifier Type: -

Identifier Source: org_study_id