- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02156375
A Pharmacokinetic Study of Single-Dose Intravenous Ustekinumab Delivered in 2 Different Liquid in Vial Formulations
March 21, 2016 updated by: Janssen Research & Development, LLC
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
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
140
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
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Arizona
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Tempe, Arizona, United States
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Nebraska
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Lincoln, Nebraska, United States
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New Jersey
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Neptune, New Jersey, United States
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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:
- 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
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: Ustekinumab 90 mg/mL
|
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 Names:
Participants will receive a single 6 mg/kg intravenous infusion of 5 mg/mL LIV formulation, diluted in saline, on Day 1.
Other Names:
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Experimental: Ustekinumab 5 mg/mL
|
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 Names:
Participants will receive a single 6 mg/kg intravenous infusion of 5 mg/mL LIV formulation, diluted in saline, on Day 1.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Observed Plasma Concentration (Cmax)
Time Frame: Day 0 through Day 113
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The Cmax is the maximum observed plasma concentration of study drug.
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Day 0 through Day 113
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Area under the serum concentration versus time curve from time zero to infinity (AUC[0-inf])
Time Frame: Day 0 through Day 113
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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.
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Day 0 through Day 113
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time Frame: Baseline up to Day 141
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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.
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Baseline up to Day 141
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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
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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.
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Day 0 through Day 113
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Terminal half-life (T1/2)
Time Frame: Day 0 through Day 113
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The T1/2 is the terminal half-life, that is, time required for the plasma concentration to decrease by one half.
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Day 0 through Day 113
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Total systemic clearance (CL)
Time Frame: Day 0 through Day 113
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The CL is a quantitative measure of the rate at which a drug substance is removed from the body.
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Day 0 through Day 113
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Volume of distribution (Vz)
Time Frame: Day 0 through Day 113
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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.
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Day 0 through Day 113
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Number of participants with antibodies to ustekinumab
Time Frame: Baseline, Days 57 and 113
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Number of participants with antibodies to ustekinumab (tested using a validated immunoassay method) will be reported.
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Baseline, Days 57 and 113
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
May 1, 2014
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
June 3, 2014
First Submitted That Met QC Criteria
June 3, 2014
First Posted (Estimate)
June 5, 2014
Study Record Updates
Last Update Posted (Estimate)
March 22, 2016
Last Update Submitted That Met QC Criteria
March 21, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR104186
- CNTO1275NAP1002
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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