HealthyPhase 1NCT01809353
To Assess the Pharmacokinetics and Safety of Single Doses of JNJ-54452840 in Healthy Japanese and Caucasian Participants
A Phase 1 study testing JNJ-54452840 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
Trial summary
The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the drug) and safety of JNJ-54452840 in healthy participants. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- JNJ-54452840
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Sep 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 20 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must be a healthy male with no clinically relevant abnormalities as determined by medical history, physical examination, blood chemistry assessments, hematologic assessments - Must be Japanese or Caucasian
- Japanese participants must have been born in Japan, have resided outside of Japan for no more than 5 years, and have Japanese parents and maternal and paternal grandparents
- Caucasian participants must have Caucasian parents
Who cannot join
- History of or current clinically significant medical illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- Have a known or suspected intolerance or hypersensitivity to any biologic medication or known allergies or clinically significant reactions to murine, chimeric, or human peptides or protein
- Be unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Randomized, Double-Blind, Placebo-Controlled Crossover Study to Evaluate the Pharmacokinetics and Safety of JNJ-54452840 Following Single Intravenous Doses to Healthy Japanese and Caucasian Subjects
The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the drug) and safety of JNJ-54452840 in healthy participants.
Read the detailed description
This is a Phase 1, randomized (the study treatment is assigned by chance), double-blind (neither physician nor participant knows the treatment received), placebo-controlled (one of the study treatments is inactive), four-way cross-over study (method used to switch participants from one treatment arm to another in a clinical trial) conducted in healthy male Japanese and Caucasian participants. The study will be conducted in 3 parts; a screening phase (up to 28 days), a double-blind treatment phase (28 days), and a follow-up phase (approximately 21 to 28 days). The study will be conducted in 2 groups (Group A consists of 16 Japanese participants; Group B consists of 16 Caucasian participants) over 4 treatment periods. On Day 1 of Period 1, approximately 16 eligible Japanese participants and the same number of eligible Caucasian participants will be randomly assigned to 1 of 4 treatment sequences and will receive the 4 intravenous treatments JNJ-54452840 20 mg, JNJ-54452840 80 mg, JNJ-54452840 240 mg, and placebo across the treatment periods according to the order specified by the randomization schedule.
Participants will come to the study center each time they receive study medication and will be discharged from the study center 24 hours after dosing during each treatment period after satisfactory review of all clinical safety measures. Blood samples will be drawn at time points during the treatment and follow-up periods for participants in both Group A and Group B of the study. Participants will return to the study center for a follow-up visit within approximately 7 to 10 days after the last study procedure in the last treatment period for safety assessments, followed by another visit within approximately 21 to 28 days for assessment of anti -beta-1-AR (adrenergic receptor) auto-antibodies in blood (auto-antibodies targeting the human beta-1-AR antibody). If anti-beta-1-AR auto-antibodies are detected at this second follow-up visit, additional testing will be performed every 3 months until autoantibody levels fall below the level of detection of the assay or for 1 year, whichever occurs earlier. Participants in Group A and Group B will be involved in the study for approximately 12 weeks and up to 1 year if they develop anti -beta-1-AR auto-antibodies . Safety of the participants will be monitored throughout the study.
- Conditions
- Healthy
- Being tested
- JNJ-54452840, Placebo
- Keywords
- Healthy, Japanese, Caucasian, Male, Pharmacokinetic, JNJ-54452840
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-54452840Drug
Single intravenous (medication is injected into a vein) doses of 20 mg, 80 mg, and 240 mg
PlaceboOther
Single matching intravenous dose
| Study group | Role | What they receive |
|---|---|---|
| Group A: JNJ-54452840 20 mg | Experimental | Each participant will receive 20 mg of JNJ-54452840 as a single intravenous dose. Receives: Drug: JNJ-54452840 |
| Group A: JNJ-54452840 80 mg | Experimental | Each participant will receive 80 mg of JNJ-54452840 as a single intravenous dose. Receives: Drug: JNJ-54452840 |
| Group A: JNJ-54452840 240 mg | Experimental | Each participant will receive 240 mg of JNJ-54452840 as a single intravenous dose. Receives: Drug: JNJ-54452840 |
| Group A: Placebo | Placebo comparator | Each participant will receive matching placebo as a single intravenous dose. Receives: Other: Placebo |
| Group B: JNJ-54452840 20 mg | Experimental | Each participant will receive 20 mg of JNJ-54452840 as a single intravenous dose. Receives: Drug: JNJ-54452840 |
| Group B: JNJ-54452840 80 mg | Experimental | Each participant will receive 80 mg of JNJ-54452840 as a single intravenous dose. Receives: Drug: JNJ-54452840 |
| Group B: JNJ-54452840 240 mg | Experimental | Each participant will receive 240 mg of JNJ-54452840 as a single intravenous dose. Receives: Drug: JNJ-54452840 |
| Group B: Placebo | Placebo comparator | Each participant will receive matching placebo as a single intravenous dose. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum concentrations of JNJ-54452840
Serum concentrations of JNJ-54452840 will be used to determine pharmacokinetic parameters for JNJ-54452840
Measured: Up to Day 2
Secondary outcomes (1)
Number of participants with an adverse event as a measure of safety
Measured: Up to Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2013 (estimated)
- Study startJul 2013
- Primary completionSep 2014
- Study completionSep 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 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
- NCT01809353
- Sponsor's protocol ID
- CR100982
- Other IDs
- 54452840HFA1001
- Status last verified
- Mar 2015
- First submitted
- 8 Mar 2013
- Last updated
- 23 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Double-Blind, Placebo-Controlled Crossover Study to Evaluate the Pharmacokinetics and Safety of JNJ-54452840 Following Single Intravenous Doses to Healthy Japanese and Caucasian Subjects
- ClinicalTrials.gov ID
- NCT01809353
- Acronym / sponsor ID
- CR100982
- Conditions
- Healthy
- Keywords
- Healthy, Japanese, Caucasian, Male, Pharmacokinetic, JNJ-54452840
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 12 Mar 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.
The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the drug) and safety of JNJ-54452840 in healthy participants.
Detailed description
This is a Phase 1, randomized (the study treatment is assigned by chance), double-blind (neither physician nor participant knows the treatment received), placebo-controlled (one of the study treatments is inactive), four-way cross-over study (method used to switch participants from one treatment arm to another in a clinical trial) conducted in healthy male Japanese and Caucasian participants. The study will be conducted in 3 parts; a screening phase (up to 28 days), a double-blind treatment phase (28 days), and a follow-up phase (approximately 21 to 28 days). The study will be conducted in 2 groups (Group A consists of 16 Japanese participants; Group B consists of 16 Caucasian participants) over 4 treatment periods. On Day 1 of Period 1, approximately 16 eligible Japanese participants and the same number of eligible Caucasian participants will be randomly assigned to 1 of 4 treatment sequences and will receive the 4 intravenous treatments JNJ-54452840 20 mg, JNJ-54452840 80 mg, JNJ-54452840 240 mg, and placebo across the treatment periods according to the order specified by the randomization schedule.
Participants will come to the study center each time they receive study medication and will be discharged from the study center 24 hours after dosing during each treatment period after satisfactory review of all clinical safety measures. Blood samples will be drawn at time points during the treatment and follow-up periods for participants in both Group A and Group B of the study. Participants will return to the study center for a follow-up visit within approximately 7 to 10 days after the last study procedure in the last treatment period for safety assessments, followed by another visit within approximately 21 to 28 days for assessment of anti -beta-1-AR (adrenergic receptor) auto-antibodies in blood (auto-antibodies targeting the human beta-1-AR antibody). If anti-beta-1-AR auto-antibodies are detected at this second follow-up visit, additional testing will be performed every 3 months until autoantibody levels fall below the level of detection of the assay or for 1 year, whichever occurs earlier. Participants in Group A and Group B will be involved in the study for approximately 12 weeks and up to 1 year if they develop anti -beta-1-AR auto-antibodies . Safety of the participants will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Group A: JNJ-54452840 20 mg | Experimental | Drug: JNJ-54452840Each participant will receive 20 mg of JNJ-54452840 as a single intravenous dose. |
| Group A: JNJ-54452840 80 mg | Experimental | Drug: JNJ-54452840Each participant will receive 80 mg of JNJ-54452840 as a single intravenous dose. |
| Group A: JNJ-54452840 240 mg | Experimental | Drug: JNJ-54452840Each participant will receive 240 mg of JNJ-54452840 as a single intravenous dose. |
| Group A: Placebo | Placebo comparator | Other: PlaceboEach participant will receive matching placebo as a single intravenous dose. |
| Group B: JNJ-54452840 20 mg | Experimental | Drug: JNJ-54452840Each participant will receive 20 mg of JNJ-54452840 as a single intravenous dose. |
| Group B: JNJ-54452840 80 mg | Experimental | Drug: JNJ-54452840Each participant will receive 80 mg of JNJ-54452840 as a single intravenous dose. |
| Group B: JNJ-54452840 240 mg | Experimental | Drug: JNJ-54452840Each participant will receive 240 mg of JNJ-54452840 as a single intravenous dose. |
| Group B: Placebo | Placebo comparator | Other: PlaceboEach participant will receive matching placebo as a single intravenous dose. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Must be a healthy male with no clinically relevant abnormalities as determined by medical history, physical examination, blood chemistry assessments, hematologic assessments - Must be Japanese or Caucasian
- Japanese participants must have been born in Japan, have resided outside of Japan for no more than 5 years, and have Japanese parents and maternal and paternal grandparents
- Caucasian participants must have Caucasian parents
Key exclusion criteria (3 listed)
- History of or current clinically significant medical illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- Have a known or suspected intolerance or hypersensitivity to any biologic medication or known allergies or clinically significant reactions to murine, chimeric, or human peptides or protein
- Be unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins
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 |
|---|---|---|
| JNJ-54452840Single intravenous (medication is injected into a vein) doses of 20 mg, 80 mg, and 240 mg | Drug | Group A: JNJ-54452840 20 mg, Group A: JNJ-54452840 240 mg, Group A: JNJ-54452840 80 mg, Group B: JNJ-54452840 20 mg, Group B: JNJ-54452840 240 mg, Group B: JNJ-54452840 80 mg |
| PlaceboSingle matching intravenous dose | Other | Group A: Placebo, Group B: Placebo |
Primary outcome
Serum concentrations of JNJ-54452840
Time frame: Up to Day 2
Serum concentrations of JNJ-54452840 will be used to determine pharmacokinetic parameters for JNJ-54452840
1 secondary outcome
Number of participants with an adverse event as a measure of safety
Time frame: Up to Day 2
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 23 Mar 2015.
- A Phase 1 Randomized, Double-Blind, Placebo-Controlled Crossover Study to Evaluate the Pharmacokinetics and Safety of JNJ-54452840 Following Single Intravenous Doses to Healthy Male Japanese and Caucasian 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-54452840 in people with Healthy, run by Janssen Research & Development, LLC at 1 site 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 3 inclusion and 3 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 23 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Serum concentrations of JNJ-54452840 (time frame: Up to Day 2). 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 23 Mar 2015.