A Study to Assess the Pharmacokinetic Comparability of Guselkumab (CNTO1959) When Delivered by 2 Different Devices and as 2 Formulations in Healthy Participants

January 23, 2020 updated by: Janssen Research & Development, LLC

Phase 1, Open-label, Randomized, Parallel Study to Assess the Pharmacokinetic Comparability of 2 Formulations and to Evaluate Pharmacokinetic Comparability of Guselkumab (CNTO1959) Delivered by 2 Different Devices in Healthy Subjects

The purpose of this study is to evaluate the pharmacokinetic (what the body does to the medication) comparability of guselkumab in lyophilized and liquid formulations. Also to evaluate pharmacokinetic comparability of liquid formulation of guselkumab when delivered as prefilled syringe with UltraSafe Passive Delivery System [PFS-U] or with a prefilled syringe facilitated injection device [PFS FID]) following a single subcutaneous (SC) administration of 100 mg guselkumab in healthy participants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), parallel study (each group of participants will be treated at the same time) of guselkumab in healthy participants. Approximately 140 participants will be randomly assigned in the ratio 2:2:2:1 in to 4 treatment groups: Group 1 (SC injection of lyophilized formulation), Group 2 (subcutaneous [SC] injection of liquid formulation with PFS-U), Group 3 (SC injection of liquid formulation with PFS-FID), and Group 4 (IV infusion of liquid formulation). The study consists of 3 phases: screening (up to 4 weeks), open-label treatment and inpatient follow up (1 week) and outpatient follow up (11 weeks). Safety evaluations will include assessment of adverse events, vital signs, physical examination, electrocardiograms, injection-site reactions, and clinical laboratory tests. The total duration of the study for each participant will be approximately 16 weeks.

Study Type

Interventional

Enrollment (Actual)

141

Phase

  • 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
    • New Jersey
      • Neptune, New Jersey, 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

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy participant with no clinically significant abnormalities
  • Have a weight in the range of 60 kg to 90 kg for male participants; have a weight in the range of 50 kg to 80 kg for female participants
  • Have a body mass index (BMI) of 18.5 kg/m2 to 29.0 kg/m2
  • Agrees to protocol-defined use of effective contraception

Exclusion Criteria:

  • Participant has a history of any clinically significant medical illness including liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances, ophthalmological disorders, neoplastic disease, urinary tract diseases, or dermatological disease
  • Currently have any known malignancy or have a history of malignancy
  • Participant has a known or suspected intolerance or hypersensitivity to any biologic medication or known allergies or clinically significant reactions to murine, chimeric, or human proteins to monoclonal antibodies or antibody fragments
  • Have had a Bacillus Calmette-Guérin (BCG) vaccination within 12 months of screening

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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
40 participants will receive a single subcutaneous (SC) injection of 100 mg guselkumab prepared from lyophilized formulation.
Drug: Guselkumab (lyophilized formulation)
Participants will receive a single SC injection of 100 mg guselkumab prepared from lyophilized formulation.
Other Names:
  • CNTO1959
Experimental: Group 2
40 participants will receive a single SC injection of 100 mg guselkumab, liquid formulation with UltraSafe Passive Delivery System (PFS-U).
Drug: Guselkumab (liquid formulation with PFS-U)
Participants will receive a single SC injection of 100 mg guselkumab, liquid formulation with PFS-U.
Other Names:
  • CNTO1959
Experimental: Group 3
40 participants will receive a single SC injection of 100 mg guselkumab, liquid formulation with a prefilled syringe facilitated injection device (PFS FID).
Drug: Guselkumab (liquid formulation with PFS FID)
Participants will receive a single SC injection of 100 mg guselkumab, liquid formulation with PFS FID.
Other Names:
  • CNTO1959
Experimental: Group 4
20 participants will receive a single intravenous (IV) infusion of 100 mg guselkumab prepared from liquid formulation.
Drug: Guselkumab (liquid formulation)
Participants will receive a single IV infusion of 100 mg guselkumab prepared from liquid formulation.
Other Names:
  • CNTO1959

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum observed serum concentration (Cmax) of guselkumab
Time Frame: Day 1 through Week 12
Day 1 through Week 12
Area under the curve (AUC) from time 0 to 70 days of guselkumab
Time Frame: Day 1 through Week 12
Day 1 through Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events as a measure of safety and tolerability
Time Frame: Up to 12 weeks
Up to 12 weeks
Absolute bioavailability of guselkumab
Time Frame: Day 1 through Week 12
Bioavailability will be evaluated by using 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 guselkumab and multiplied by 100.
Day 1 through Week 12
Immunogenicity of guselkumab
Time Frame: Day 1 through Week 12
Plasma levels of antibodies to guselkumab for evaluation of potential immunogenicity.
Day 1 through Week 12

Collaborators and Investigators

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

Sponsor

Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (Actual)

May 9, 2013

Primary Completion (Actual)

September 20, 2013

Study Completion (Actual)

October 9, 2013

Study Registration Dates

First Submitted

May 28, 2013

First Submitted That Met QC Criteria

May 28, 2013

First Posted (Estimate)

May 31, 2013

Study Record Updates

Last Update Posted (Actual)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 23, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR100969
  • CNTO1959NAP1001 (Other Identifier: Janssen Research & Development, LLC)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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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