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Completed

NCT Number: NCT02156375

A Pharmacokinetic Study of Single-Dose 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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Tempe, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ustekinumab

Drug

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: STELARA®

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Day 0 through Day 113

    The Cmax is the maximum observed plasma concentration of study drug.

  2. Area under the serum concentration versus time curve from time zero to infinity (AUC[0-inf])

    Time frame: Day 0 through Day 113

    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 outcomes

  1. Number of participants with adverse events (AEs) and serious adverse events (SAEs)

    Time frame: Baseline up to Day 141

    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.

  2. 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

    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.

  3. Terminal half-life (T1/2)

    Time frame: Day 0 through Day 113

    The T1/2 is the terminal half-life, that is, time required for the plasma concentration to decrease by one half.

  4. Total systemic clearance (CL)

    Time frame: Day 0 through Day 113

    The CL is a quantitative measure of the rate at which a drug substance is removed from the body.

  5. Volume of distribution (Vz)

    Time frame: Day 0 through Day 113

    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.

  6. Number of participants with antibodies to ustekinumab

    Time frame: Baseline, Days 57 and 113

    Number of participants with antibodies to ustekinumab (tested using a validated immunoassay method) will be reported.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 5, 2014
Registry last updated
Mar 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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