HealthyPhase 1NCT02079545
Bioavailability and Pharmacokinetics Study of Sirukumab in Healthy Male Participants
A Phase 1 study testing Sirukumab (IV infusion), Sirukumab (SC injection with PFS-U) and Sirukumab (SC injection with PFS-AI) in people with Healthy, run by Janssen Research & Development, LLC at 2 sites in United States.
Trial summary
The purpose of the study is to assess the bioavailability (the extent to which a medication becomes available to the body) of subcutaneously (under the skin using a needle) administered sirukumab and to compare the pharmacokinetics of sirukumab administered subcutaneously using a pre-filled syringe fitted with the… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Sirukumab (IV infusion), Sirukumab (SC injection with PFS-U) and Sirukumab (SC injection with PFS-AI)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2014to Jan 2015
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must have a weight in the range of 50.0 kg to 100.0 kg, inclusive
- Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram performed at screening
- Each participant must sign an informed consent form (ICF) indicating that he understands the purpose of and procedures required for the study and is willing to participate in the study
- Must be willing and able to adhere to the study visit schedule and other protocol requirements
- Must agree to abstain from alcohol intake 48 hours before administration of study agent and during the inpatient period of the study
Who cannot join
- Have any known malignancy or history of malignancy, except for nonmelanoma skin cancer that has been treated with no evidence of recurrence for at least 3 months before Day 1
- Have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly
- Have any underlying physical or psychological medical condition that, in the opinion of the investigator, would make it unlikely that the participant will complete the study
- Have evidence of any chronic medical condition requiring prescription medications (eg, hypertension, elevated cholesterol/triglycerides, asthma, or diabetes)
- Have a history of or current elevations in triglycerides that required treatment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Lincoln, Nebraska
Study site
Tempe, Arizona
About this study
Official title: A Phase 1, Randomized, Open-label, Parallel-design Study to Assess Absolute Bioavailability and Single-dose Pharmacokinetics Following Subcutaneous Administration of Sirukumab Delivered By A Pre-filled Syringe Fitted With UltraSafe Passive™ Delivery System or an Autoinjector in Healthy Male Subjects
The purpose of the study is to assess the bioavailability (the extent to which a medication becomes available to the body) of subcutaneously (under the skin using a needle) administered sirukumab and to compare the pharmacokinetics of sirukumab administered subcutaneously using a pre-filled syringe fitted with the UltraSafe Passive™ Delivery system (PFS-U) with the SmartJect™ Autoinjector (PFS-AI) in healthy male participants.
Read the detailed description
This is a randomized (the study medication is assigned by chance), open-label (all people know the identity of the intervention), parallel-group (each group of participants will be treated at the same time), multicenter; single-dose study. Approximately 138 participants will be randomly allocated in a 3:3:3:7:7 ratio to 1 of the 5 treatment groups as follows: Group 1 (a single intravenous infusion of 100 mg sirukumab), Group 2 (a single subcutaneous [SC] injection of 50 mg sirukumab with PFS-U), Group 3 (a single SC injection of 50 mg sirukumab with PFS-AI, Group 4 (a single SC injection of 100 mg sirukumab with PFS-U), and Group 5 (a single SC injection of 100 mg sirukumab with PFS-AI). Randomization will be stratified by body weight (50.0 kg to <70.0 kg, 70.0 kg to <85.0 kg, 85.0 kg to 100.0 kg). Participants will be hospitalized in the study unit for administration of study drug and will be discharged after completion of all scheduled assessments on Day 5. Participants will be required to return to the study unit for outpatient visits on Days 6 and 7, followed by weekly/biweekly outpatient visits, and then a safety follow-up for a total of 13 weeks after study drug administration. Safety evaluations will include assessment of adverse events, physical examination, vital signs, injection site and infusion reactions, electrocardiogram, and clinical laboratory tests. The maximum study duration for each participant will be 120 days.
- Conditions
- Healthy
- Being tested
- Sirukumab (IV infusion), Sirukumab (SC injection with PFS-U), Sirukumab (SC injection with PFS-AI)
- Keywords
- Healthy, Bioavailability, Pharmacokinetics, Sirukumab, Subcutaneous, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sirukumab (IV infusion)Drug
Participants will receive a single IV infusion of 100 mg sirukumab.
Sirukumab (SC injection with PFS-U)Drug
Participants will receive a single SC injection of 50 mg sirukumab with PFS-U.
Sirukumab (SC injection with PFS-AI)Drug
Participants will receive a single SC injection of 50 mg sirukumab with PFS-AI.
Sirukumab (SC injection with PFS-U)Drug
Participants will receive a single SC injection of 100 mg sirukumab with PFS-U.
Sirukumab (SC injection with PFS-AI)Drug
Participants will receive a single SC injection of 100 mg sirukumab with PFS-AI.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 18 participants will receive a single intravenous (IV) infusion of 100 mg sirukumab Receives: Drug: Sirukumab (IV infusion) |
| Group 2 | Experimental | 18 participants will receive a single subcutaneous (SC) injection of 50 mg sirukumab using a Pre-filled Syringe (PFS) fitted with the UltraSafe Passive™ Delivery System (PFS-U) Receives: Drug: Sirukumab (SC injection with PFS-U) |
| Group 3 | Experimental | 18 participants will receive a single SC injection of 50 mg sirukumab using the SmartJect™ Autoinjector (PFS-AI) Receives: Drug: Sirukumab (SC injection with PFS-AI) |
| Group 4 | Experimental | 42 participants will receive a single SC injection of 100 mg sirukumab using a PFS-U Receives: Drug: Sirukumab (SC injection with PFS-U) |
| Group 5 | Experimental | 42 participants will receive a single SC injection of 100 mg sirukumab using a PFS-AI Receives: Drug: Sirukumab (SC injection with PFS-AI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute bioavailability of 100 mg sirukumab administered subcutanoeusly
Bioavailability will be evaluated by using the 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 sirukumab and multiplied by 100.
Measured: Up to Week 13
Maximum Observed Serum Concentration (Cmax) of 100 mg sirukumab administered subcutanoeusly
The Serum Concentration (Cmax) is defined as maximum observed analyte concentration.
Measured: Up to Week 13
Area Under the Serum Concentration-Time Curve From Time Zero to 77 days (AUC0-77d) of 100 mg sirukumab administered subcutanoeusly
Measured: Up to Week 13
Secondary outcomes (2)
Number of participants with adverse events
Measured: Up to Week 13
Immunogenicity of sirukumab
Serum levels of antibodies to sirukumab will be used to evaluate potential immunogenicity.
Measured: Up to Week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionJan 2015
- Study completionJan 2015
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02079545
- Sponsor's protocol ID
- CR103367
- Other IDs
- CNTO136NAP1003
- Status last verified
- Mar 2016
- First submitted
- 4 Mar 2014
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 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 Assess Absolute Bioavailability and Single-dose Pharmacokinetics Following Subcutaneous Administration of Sirukumab Delivered By A Pre-filled Syringe Fitted With UltraSafe Passive™ Delivery System or an Autoinjector in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02079545
- Acronym / sponsor ID
- CR103367
- Conditions
- Healthy
- Keywords
- Healthy, Bioavailability, Pharmacokinetics, Sirukumab, Subcutaneous, Male
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- Mar 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 5 Mar 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 the study is to assess the bioavailability (the extent to which a medication becomes available to the body) of subcutaneously (under the skin using a needle) administered sirukumab and to compare the pharmacokinetics of sirukumab administered subcutaneously using a pre-filled syringe fitted with the UltraSafe Passive™ Delivery system (PFS-U) with the SmartJect™ Autoinjector (PFS-AI) in healthy male participants.
Detailed description
This is a randomized (the study medication is assigned by chance), open-label (all people know the identity of the intervention), parallel-group (each group of participants will be treated at the same time), multicenter; single-dose study. Approximately 138 participants will be randomly allocated in a 3:3:3:7:7 ratio to 1 of the 5 treatment groups as follows: Group 1 (a single intravenous infusion of 100 mg sirukumab), Group 2 (a single subcutaneous [SC] injection of 50 mg sirukumab with PFS-U), Group 3 (a single SC injection of 50 mg sirukumab with PFS-AI, Group 4 (a single SC injection of 100 mg sirukumab with PFS-U), and Group 5 (a single SC injection of 100 mg sirukumab with PFS-AI). Randomization will be stratified by body weight (50.0 kg to <70.0 kg, 70.0 kg to <85.0 kg, 85.0 kg to 100.0 kg). Participants will be hospitalized in the study unit for administration of study drug and will be discharged after completion of all scheduled assessments on Day 5. Participants will be required to return to the study unit for outpatient visits on Days 6 and 7, followed by weekly/biweekly outpatient visits, and then a safety follow-up for a total of 13 weeks after study drug administration. Safety evaluations will include assessment of adverse events, physical examination, vital signs, injection site and infusion reactions, electrocardiogram, and clinical laboratory tests. The maximum study duration for each participant will be 120 days.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Sirukumab (IV infusion)18 participants will receive a single intravenous (IV) infusion of 100 mg sirukumab |
| Group 2 | Experimental | Drug: Sirukumab (SC injection with PFS-U)18 participants will receive a single subcutaneous (SC) injection of 50 mg sirukumab using a Pre-filled Syringe (PFS) fitted with the UltraSafe Passive™ Delivery System (PFS-U) |
| Group 3 | Experimental | Drug: Sirukumab (SC injection with PFS-AI)18 participants will receive a single SC injection of 50 mg sirukumab using the SmartJect™ Autoinjector (PFS-AI) |
| Group 4 | Experimental | Drug: Sirukumab (SC injection with PFS-U)42 participants will receive a single SC injection of 100 mg sirukumab using a PFS-U |
| Group 5 | Experimental | Drug: Sirukumab (SC injection with PFS-AI)42 participants will receive a single SC injection of 100 mg sirukumab using a PFS-AI |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Must have a weight in the range of 50.0 kg to 100.0 kg, inclusive
- Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram performed at screening
- Each participant must sign an informed consent form (ICF) indicating that he understands the purpose of and procedures required for the study and is willing to participate in the study
- Must be willing and able to adhere to the study visit schedule and other protocol requirements
- Must agree to abstain from alcohol intake 48 hours before administration of study agent and during the inpatient period of the study
Key exclusion criteria (5 listed)
- Have any known malignancy or history of malignancy, except for nonmelanoma skin cancer that has been treated with no evidence of recurrence for at least 3 months before Day 1
- Have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly
- Have any underlying physical or psychological medical condition that, in the opinion of the investigator, would make it unlikely that the participant will complete the study
- Have evidence of any chronic medical condition requiring prescription medications (eg, hypertension, elevated cholesterol/triglycerides, asthma, or diabetes)
- Have a history of or current elevations in triglycerides that required treatment
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 |
|---|---|---|
| Sirukumab (IV infusion)Participants will receive a single IV infusion of 100 mg sirukumab. | Drug | Group 1 |
| Sirukumab (SC injection with PFS-U)Participants will receive a single SC injection of 50 mg sirukumab with PFS-U. | Drug | Group 2 |
| Sirukumab (SC injection with PFS-AI)Participants will receive a single SC injection of 50 mg sirukumab with PFS-AI. | Drug | Group 3 |
| Sirukumab (SC injection with PFS-U)Participants will receive a single SC injection of 100 mg sirukumab with PFS-U. | Drug | Group 4 |
| Sirukumab (SC injection with PFS-AI)Participants will receive a single SC injection of 100 mg sirukumab with PFS-AI. | Drug | Group 5 |
Primary outcome
Absolute bioavailability of 100 mg sirukumab administered subcutanoeusly
Time frame: Up to Week 13
Bioavailability will be evaluated by using the 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 sirukumab and multiplied by 100.
Maximum Observed Serum Concentration (Cmax) of 100 mg sirukumab administered subcutanoeusly
Time frame: Up to Week 13
The Serum Concentration (Cmax) is defined as maximum observed analyte concentration.
Area Under the Serum Concentration-Time Curve From Time Zero to 77 days (AUC0-77d) of 100 mg sirukumab administered subcutanoeusly
Time frame: Up to Week 13
2 secondary outcomes
Number of participants with adverse events
Time frame: Up to Week 13
Immunogenicity of sirukumab
Time frame: Up to Week 13
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 9 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
2 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 Sirukumab (IV infusion), Sirukumab (SC injection with PFS-U) and Sirukumab (SC injection with PFS-AI) in people with Healthy, run by Janssen Research & Development, LLC at 2 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 5 inclusion and 5 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 9 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 2 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?
Absolute bioavailability of 100 mg sirukumab administered subcutanoeusly (time frame: Up to Week 13). The study lists 3 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 9 Mar 2016.