HealthyPhase 1NCT02156375
A Pharmacokinetic Study of Single-Dose Intravenous Ustekinumab Delivered in 2 Different Liquid in Vial Formulations
A Phase 1 study testing Ustekinumab in people with Healthy, run by Janssen Research & Development, LLC at 3 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ustekinumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2014to Dec 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Lincoln, Nebraska
Study site
Neptune City, New Jersey
Study site
Tempe, Arizona
About this study
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
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Ustekinumab
- Keywords
- Healthy, Ustekinumab, STELARA®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UstekinumabDrug
Also called STELARA®
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.
UstekinumabDrug
Also called STELARA®
Participants will receive a single 6 mg/kg intravenous infusion of 5 mg/mL LIV formulation, diluted in saline, on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Ustekinumab 90 mg/mL | Experimental | Not described Receives: Drug: Ustekinumab |
| Ustekinumab 5 mg/mL | Experimental | Not described Receives: Drug: Ustekinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax)
The Cmax is the maximum observed plasma concentration of study drug.
Measured: Day 0 through Day 113
Area under the serum concentration versus time curve from time zero to infinity (AUC[0-inf])
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.
Measured: Day 0 through Day 113
Secondary outcomes (6)
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
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.
Measured: Baseline up to Day 141
Area under the serum concentration versus time curve from time zero to the time corresponding to the last quantifiable concentration (AUC[0-last])
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.
Measured: Day 0 through Day 113
Terminal half-life (T1/2)
The T1/2 is the terminal half-life, that is, time required for the plasma concentration to decrease by one half.
Measured: Day 0 through Day 113
Total systemic clearance (CL)
The CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Measured: Day 0 through Day 113
Volume of distribution (Vz)
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.
Measured: Day 0 through Day 113
Number of participants with antibodies to ustekinumab
Number of participants with antibodies to ustekinumab (tested using a validated immunoassay method) will be reported.
Measured: Baseline, Days 57 and 113
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02156375
- Sponsor's protocol ID
- CR104186
- Other IDs
- CNTO1275NAP1002
- Status last verified
- Mar 2016
- First submitted
- 3 Jun 2014
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02156375
- Acronym / sponsor ID
- CR104186
- Conditions
- Healthy
- Keywords
- Healthy, Ustekinumab, STELARA®
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 5 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ustekinumab 90 mg/mL | Experimental | Drug: Ustekinumab |
| Ustekinumab 5 mg/mL | Experimental | Drug: Ustekinumab |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UstekinumabAlso: STELARA®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. | Drug | Ustekinumab 90 mg/mL |
| UstekinumabAlso: STELARA®Participants will receive a single 6 mg/kg intravenous infusion of 5 mg/mL LIV formulation, diluted in saline, on Day 1. | Drug | Ustekinumab 5 mg/mL |
Primary outcome
Maximum Observed Plasma Concentration (Cmax)
Time frame: Day 0 through Day 113
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
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.
6 secondary outcomes
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time frame: Baseline up to Day 141
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
Terminal half-life (T1/2)
Time frame: Day 0 through Day 113
Total systemic clearance (CL)
Time frame: Day 0 through Day 113
Volume of distribution (Vz)
Time frame: Day 0 through Day 113
Number of participants with antibodies to ustekinumab
Time frame: Baseline, Days 57 and 113
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ustekinumab in people with Healthy, run by Janssen Research & Development, LLC at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Plasma Concentration (Cmax) (time frame: Day 0 through Day 113). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2016.