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A Pharmacokinetic Study of Single-Dose Intravenous Ustekinumab Delivered in 2 Different Liquid in Vial Formulations

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Janssen Research & Development, LLC
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT02156375
First received: June 3, 2014
Last updated: July 18, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to evaluate the pharmacokinetic (PK) (blood levels) comparability of 2 different formulations of ustekinumab, 90 milligram per milliliter (mg/mL) liquid in vial (LIV) and 5 mg/mL LIV, following a single intravenous administration of 6 milligram per kilogram (mg/kg) ustekinumab, diluted in saline, in healthy participants.


Condition Intervention Phase
Healthy
Drug: Ustekinumab
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Open-label, Parallel-design Study to Compare Single-dose Pharmacokinetics of Intravenous Ustekinumab Delivered in 2 Different Liquid in Vial Formulations

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Day 0 through Day 113 ] [ Designated as safety issue: No ]
    The Cmax is the maximum observed plasma concentration of study drug.

  • Area under the serum concentration versus time curve from time zero to infinity (AUC[0-inf]) [ Time Frame: Day 0 through Day 113 ] [ Designated as safety issue: No ]
    The AUC(0-inf) is the area under the serum concentration versus time curve from time zero to infinity with extrapolation of the terminal phase.


Secondary Outcome Measures:
  • Number of participants with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Baseline up to Day 141 ] [ Designated as safety issue: Yes ]
    An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product and does not necessarily have a causal relationship with the treatment. An SAE is any untoward medical occurrence that meets any of the following conditions: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.

  • Area under the serum concentration versus time curve from time zero to the time corresponding to the last quantifiable concentration (AUC[0-last]) [ Time Frame: Day 0 through Day 113 ] [ Designated as safety issue: No ]
    The AUC(0-last) is the area under the serum concentration versus time curve from time zero to the time corresponding to the last quantifiable concentration.

  • Terminal half-life (T1/2) [ Time Frame: Day 0 through Day 113 ] [ Designated as safety issue: No ]
    The T1/2 is the terminal half-life, that is, time required for the plasma concentration to decrease by one half.

  • Total systemic clearance (CL) [ Time Frame: Day 0 through Day 113 ] [ Designated as safety issue: No ]
    The CL is a quantitative measure of the rate at which a drug substance is removed from the body.

  • Volume of distribution (Vz) [ Time Frame: Day 0 through Day 113 ] [ Designated as safety issue: No ]
    The Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.

  • Number of participants with antibodies to ustekinumab [ Time Frame: Baseline, Days 57 and 113 ] [ Designated as safety issue: No ]
    Number of participants with antibodies to ustekinumab (tested using a validated immunoassay method) will be reported.


Estimated Enrollment: 140
Study Start Date: May 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ustekinumab 90 mg/mL Drug: Ustekinumab
Participants will receive a single 6 milligram per kilogram (mg/kg) intravenous infusion of 90 milligram per milliliter (mg/mL) liquid in vial (LIV) formulation, diluted in saline, on Day 1.
Other Name: STELARA®
Experimental: Ustekinumab 5 mg/mL Drug: Ustekinumab
Participants will receive a single 6 mg/kg intravenous infusion of 5 mg/mL LIV formulation, diluted in saline, on Day 1.
Other Name: STELARA®

Detailed Description:

This is a multicenter (when more than one hospital or medical school team work on a medical research study), randomized (study drug is assigned by chance), parallel (a clinical trial comparing the response in two or more groups of participants receiving different treatments), open-label (all people know the identity of the intervention) single-dose, inpatient/outpatient study in healthy participants. The study consists of following periods: Screening (within 28 days before study drug administration), inpatient period (Day 1 to 4) and outpatient period (up to Day 141). Eligible participants will be randomly assigned in a 1:1 ratio to either 1 of 2 treatment groups (that is, Ustekinumab 90 mg/mL or Ustekinumab 5 mg/mL) and will receive treatment on Day 1. The PK comparability of 2 different formulations of ustekinumab, diluted in saline, will be evaluated primarily. Participants' safety will be monitored throughout the study.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Have a weight in the range of 50.0 kilogram (kg) to 90.0 kg, inclusive and a body mass index (BMI) of 18.5 kilogram per square meter (kg/m^2) to 29.0 kg/m^2, inclusive
  • If a woman, she must be incapable of pregnancy or using a highly effective method of birth control
  • A woman must have a negative serum pregnancy test
  • A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control
  • Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
  • Are nonsmokers or agree to smoke no more than 10 cigarettes or 2 cigars per day throughout the study

Exclusion Criteria:

  • Participant currently has or has a history of any clinically significant medical illness or medical disorders including malignancy
  • Participant has previously received ustekinumab
  • Participant has a known or suspected intolerance or hypersensitivity to any biologic medication including ustekinumab
  • Participant has received an investigational drug within a specified period prior to the planned first dose of study drug or is currently enrolled in an investigational study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02156375

Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

Locations
United States, Arizona
Recruiting
Tempe, Arizona, United States
United States, Nebraska
Recruiting
Lincoln, Nebraska, United States
United States, New Jersey
Not yet recruiting
Neptune, New Jersey, United States
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

Additional Information:
No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02156375     History of Changes
Other Study ID Numbers: CR104186, CNTO1275NAP1002
Study First Received: June 3, 2014
Last Updated: July 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Janssen Research & Development, LLC:
Healthy
Ustekinumab
STELARA®

Additional relevant MeSH terms:
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014