Bioavailability and Pharmacokinetics Study of Sirukumab in Healthy Male Participants

NCT02079545 | Completed Phase 1

• 2 other identifiers: CR103367CNTO136NAP1003
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy

Keywords

Healthy; Bioavailability; Pharmacokinetics; Sirukumab; Subcutaneous; Male

Outcome Measures

Primary Outcomes (3)

• Absolute bioavailability of 100 mg sirukumab administered subcutanoeusly

  Bioavailability will be evaluated by using the formula: AUC from time zero to infinity with extrapolation of the terminal phase of SC injection divided by AUC from time zero to infinity with extrapolation of the terminal phase of IV infusion of sirukumab and multiplied by 100.

  Up to Week 13

• Maximum Observed Serum Concentration (Cmax) of 100 mg sirukumab administered subcutanoeusly

  The Serum Concentration (Cmax) is defined as maximum observed analyte concentration.

  Up to Week 13

• Area Under the Serum Concentration-Time Curve From Time Zero to 77 days (AUC0-77d) of 100 mg sirukumab administered subcutanoeusly

  Up to Week 13

Secondary Outcomes (2)

• Number of participants with adverse events

  Up to Week 13

• Immunogenicity of sirukumab

  Up to Week 13

Study Arms (5)

Group 1

EXPERIMENTAL

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

Drug: Sirukumab (IV infusion)

Group 2

EXPERIMENTAL

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)

Drug: Sirukumab (SC injection with PFS-U)

Group 3

EXPERIMENTAL

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

Drug: Sirukumab (SC injection with PFS-AI)

Group 4

EXPERIMENTAL

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

Drug: Sirukumab (SC injection with PFS-U)

Group 5

EXPERIMENTAL

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

Drug: Sirukumab (SC injection with PFS-AI)

Interventions

Sirukumab (IV infusion) DRUG

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

Group 1

Sirukumab (SC injection with PFS-U) DRUG

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

Group 2

Sirukumab (SC injection with PFS-AI) DRUG

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

Group 3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead
• GlaxoSmithKline: collaborator

Study Sites (2)

Unknown Facility

Tempe, Arizona, United States

Location

Unknown Facility

Lincoln, Nebraska, United States

Location

MeSH Terms

Interventions

sirukumab; Infusions, Intravenous

Intervention Hierarchy (Ancestors)

Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Infusions, Parenteral

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2014
• First Posted: March 5, 2014
• Study Start: March 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: March 9, 2016

Record last verified: 2016-03

Locations

US (2)