HealthyPhase 1NCT01866007

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

A Phase 1 study testing Guselkumab (lyophilized formulation), Guselkumab (liquid formulation with PFS-U) and Guselkumab (liquid formulation with PFS FID) in people with Healthy, run by Janssen Research & Development, LLC at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Guselkumab (lyophilized formulation), Guselkumab (liquid formulation with PFS-U) and Guselkumab (liquid formulation with PFS FID)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 141 participants
Where: 3 sitesUnited States
Study dates: 9 May 2013to 9 Oct 2013
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

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

Who cannot join

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

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

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Healthy
Being tested: Guselkumab (lyophilized formulation), Guselkumab (liquid formulation with PFS-U), Guselkumab (liquid formulation with PFS FID), Guselkumab (liquid formulation)
Keywords: Healthy, Guselkumab, CNTO1959, Pharmacokinetics, UltraSafe Passive Delivery System (PFS-U), Prefilled syringe facilitated injection device (PFS FID)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Guselkumab (lyophilized formulation)Drug
Also called CNTO1959
Participants will receive a single SC injection of 100 mg guselkumab prepared from lyophilized formulation.
Guselkumab (liquid formulation with PFS-U)Drug
Also called CNTO1959
Participants will receive a single SC injection of 100 mg guselkumab, liquid formulation with PFS-U.
Guselkumab (liquid formulation with PFS FID)Drug
Also called CNTO1959
Participants will receive a single SC injection of 100 mg guselkumab, liquid formulation with PFS FID.
Guselkumab (liquid formulation)Drug
Also called CNTO1959
Participants will receive a single IV infusion of 100 mg guselkumab prepared from liquid formulation.

Study groups in NCT01866007
Study group	Role	What they receive
Group 1	Experimental	40 participants will receive a single subcutaneous (SC) injection of 100 mg guselkumab prepared from lyophilized formulation. Receives: Drug: Guselkumab (lyophilized formulation)
Group 2	Experimental	40 participants will receive a single SC injection of 100 mg guselkumab, liquid formulation with UltraSafe Passive Delivery System (PFS-U). Receives: Drug: Guselkumab (liquid formulation with PFS-U)
Group 3	Experimental	40 participants will receive a single SC injection of 100 mg guselkumab, liquid formulation with a prefilled syringe facilitated injection device (PFS FID). Receives: Drug: Guselkumab (liquid formulation with PFS FID)
Group 4	Experimental	20 participants will receive a single intravenous (IV) infusion of 100 mg guselkumab prepared from liquid formulation. Receives: Drug: Guselkumab (liquid formulation)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (3)

Absolute bioavailability of guselkumab
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.
Measured: Day 1 through Week 12
Immunogenicity of guselkumab
Plasma levels of antibodies to guselkumab for evaluation of potential immunogenicity.
Measured: Day 1 through Week 12
Number of participants with adverse events as a measure of safety and tolerability
Measured: Up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 May 20139 Oct 2013

First posted31 May 2013 (estimated)
Study start9 May 2013
Primary completion20 Sep 2013
Study completion9 Oct 2013

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: 141 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01866007
Sponsor's protocol ID: CR100969
Other IDs: CNTO1959NAP1001
Status last verified: Jan 2020
First submitted: 28 May 2013
Last updated: 27 Jan 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01866007
Acronym / sponsor ID: CR100969
Conditions: Healthy
Keywords: Healthy, Guselkumab, CNTO1959, Pharmacokinetics, UltraSafe Passive Delivery System (PFS-U), Prefilled syringe facilitated injection device (PFS FID)
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 141 participants (actual)
Lead sponsor: Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
Study start: 9 May 2013 (actual)
Primary completion: 20 Sep 2013 (actual)
Study completion: 9 Oct 2013 (actual)
First posted: 31 May 2013 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

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

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

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
Guselkumab (lyophilized formulation)Also: CNTO1959Participants will receive a single SC injection of 100 mg guselkumab prepared from lyophilized formulation.	Drug	Group 1
Guselkumab (liquid formulation with PFS-U)Also: CNTO1959Participants will receive a single SC injection of 100 mg guselkumab, liquid formulation with PFS-U.	Drug	Group 2
Guselkumab (liquid formulation with PFS FID)Also: CNTO1959Participants will receive a single SC injection of 100 mg guselkumab, liquid formulation with PFS FID.	Drug	Group 3
Guselkumab (liquid formulation)Also: CNTO1959Participants will receive a single IV infusion of 100 mg guselkumab prepared from liquid formulation.	Drug	Group 4

Primary outcome

Maximum observed serum concentration (Cmax) of guselkumab
Time frame: 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

3 secondary outcomes

Absolute bioavailability of guselkumab
Time frame: Day 1 through Week 12
Immunogenicity of guselkumab
Time frame: Day 1 through Week 12
Number of participants with adverse events as a measure of safety and tolerability
Time frame: Up to 12 weeks

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 27 Jan 2020.
Phase 1, Open-label, Randomized, Parallel Study to Assess the Pharmacokinetic Comparability of 2 Formulations and to Evaluate Pharmacokinetic Comparability of Guselkumab (CNTO 1959) Delivered by 2 Different Devices in Healthy SubjectsLink provided by the sponsor.

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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?

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 4 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 27 Jan 2020. 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 serum concentration (Cmax) of guselkumab (time frame: Day 1 through Week 12). 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?

On the ClinicalTrials.gov record for NCT01866007.

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 27 Jan 2020.