Bioavailability and Pharmacokinetics Study of Sirukumab in Healthy Male Participants

March 8, 2016 updated by: Janssen Research & Development, LLC

A Phase 1, Randomized, Open-label, Parallel-design Study to Assess Absolute Bioavailability and Single-dose Pharmacokinetics Following Subcutaneous Administration of Sirukumab Delivered By A Pre-filled Syringe Fitted With UltraSafe Passive™ Delivery System or an Autoinjector in Healthy Male Subjects

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
144

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tempe, Arizona, United States
    • Nebraska
      • Lincoln, Nebraska, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1
18 participants will receive a single intravenous (IV) infusion of 100 mg sirukumab
Drug: Sirukumab (IV infusion)
Participants will receive a single IV infusion of 100 mg sirukumab.
Experimental: 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)
Drug: Sirukumab (SC injection with PFS-U)
Participants will receive a single SC injection of 50 mg sirukumab with PFS-U.
Drug: Sirukumab (SC injection with PFS-U)
Participants will receive a single SC injection of 100 mg sirukumab with PFS-U.
Experimental: Group 3
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)
Participants will receive a single SC injection of 50 mg sirukumab with PFS-AI.
Drug: Sirukumab (SC injection with PFS-AI)
Participants will receive a single SC injection of 100 mg sirukumab with PFS-AI.
Experimental: Group 4
42 participants will receive a single SC injection of 100 mg sirukumab using a PFS-U
Drug: Sirukumab (SC injection with PFS-U)
Participants will receive a single SC injection of 50 mg sirukumab with PFS-U.
Drug: Sirukumab (SC injection with PFS-U)
Participants will receive a single SC injection of 100 mg sirukumab with PFS-U.
Experimental: Group 5
42 participants will receive a single SC injection of 100 mg sirukumab using a PFS-AI
Drug: Sirukumab (SC injection with PFS-AI)
Participants will receive a single SC injection of 50 mg sirukumab with PFS-AI.
Drug: Sirukumab (SC injection with PFS-AI)
Participants will receive a single SC injection of 100 mg sirukumab with PFS-AI.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Absolute bioavailability of 100 mg sirukumab administered subcutanoeusly
Time Frame: Up to Week 13
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
Time Frame: Up to Week 13
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
Time Frame: Up to Week 13
Up to Week 13

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events
Time Frame: Up to Week 13
Up to Week 13
Immunogenicity of sirukumab
Time Frame: Up to Week 13
Serum levels of antibodies to sirukumab will be used to evaluate potential immunogenicity.
Up to Week 13

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 9, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR103367
  • CNTO136NAP1003 (Other Identifier: Janssen Research & Development, LLC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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