HealthyPhase 1NCT01902550
A Crossover Study to Evaluate the Effect of JNJ-54452840 on Pharmacodynamics of Metoprolol Tartrate Immediate-Release in Healthy Participants
A Phase 1 study testing Metoprolol tartrate immediate-release (metoprolol IR) and 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 evaluate effect of co-administration of JNJ-54452840 and metoprolol tartrate immediate-release (metoprolol IR) compared to metoprolol IR alone on the exercise heart rate and blood pressure measured at the end of each 3-minute exercise test in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Metoprolol tartrate immediate-release (metoprolol IR) and JNJ-54452840
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to May 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be a healthy non-smoking male with no clinically relevant abnormalities
- Able to perform upright bicycle ergometer exercise test and be able to achieve greater than or equal to 80 percent of maximum heart rate (HR) determined as (220 beats per minute [bpm]-age) during the last 10 seconds of the 3rd minute of exercise test
- Agree to abstain from caffeine (example, coffee, tea, chocolate, or caffeine-containing soft drinks) intake during the inpatient portion of the study
- Participants with body mass index between 18 and 32 kilogram per square meter (kg/m^2) and body weight greater than or equal to 50 kilogram (Kg) at screening
Who cannot join
- Contraindication to metoprolol tartrate immediate release (metoprolol IR)
- Resting HR less than 50 bpm and blood pressure less than 110/70 millimeter of mercury (mmHg)
- Physical disability that would preclude safe and adequate exercise test performance
- History of or current clinically significant medical illness that the Investigator considers should exclude the subject or that could interfere with the interpretation of the study results
- Determined to have variant cytochrome P4502D6 (CYP2D6) alleles encoding for altered metabolism
- 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 proteins
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, 2-Period Crossover Study to Evaluate the Effect of Single Dose JNJ-54452840 on Pharmacodynamics of Metoprolol Tartrate Immediate-Release in Healthy Subjects
The purpose of this study is to evaluate effect of co-administration of JNJ-54452840 and metoprolol tartrate immediate-release (metoprolol IR) compared to metoprolol IR alone on the exercise heart rate and blood pressure measured at the end of each 3-minute exercise test in healthy participants.
Read the detailed description
This is a Phase 1, randomized (the study drug is assigned by chance), single-center, double-blind (neither physician nor participant knows the treatment that the participant receives) and 2-period crossover (participants may receive different interventions sequentially during the trial) study of JNJ-54452840 and metoprolol tartrate in healthy participants. The duration of study will be up to 7 weeks per participant and up to 1 year for participants if they develop anti-beta 1-AR (adrenergic receptor) auto-antibodies (auto-antibodies targeting the human beta-1-AR, antibody is a type of protein that helps protect the body against foreign matter, such as bacteria and viruses). The study consists of 3 parts: Screening (that is, up to 14 days before study commences on Day 1); Treatment (consists of either metoprolol IR and JNJ-54452840 or metoprolol IR and Placebo for 8 days, in subsequent two-treatment periods, separated by wash-out period of 2-7 days); and Follow-up (that is, 7-10 days after last study dose for safety assessment; followed by another visit after 21-28 days of last study dose for assessment of anti beta-1-AR auto-antibodies in blood). Any potential interaction between JNJ-54452840 and metoprolol tartrate IR will primarily be evaluated by measuring exercise induced heart rate (that is, post exercise). Participants' safety will be monitored throughout the study. If beta-1-AR-auto-antibodies are detected at the follow up visit 21-28 days after last treatment period study procedure, additional testing will be performed every 3 months until auto-antibody levels fall below the level of detection of the assay or for 1 year, whichever occurs earlier.
- Conditions
- Healthy
- Being tested
- Metoprolol tartrate immediate-release (metoprolol IR), JNJ-54452840, Placebo
- Keywords
- Healthy, JNJ-54452840, Metoprolol Tartrate Immediate-Release, Placebo, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metoprolol tartrate immediate-release (metoprolol IR)Drug
Metoprolol IR will be administered as single oral dose of 100 mg tablet or capsule.
JNJ-54452840Drug
JNJ-54452840 (12 ml solution containing 240 mg JNJ-54452840) will be administered intravenously over 1 minute.
PlaceboDrug
Matching Placebo (normal saline) to JNJ-54452840 will be administered intravenously over 1 minute on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Metoprolol plus placebo then Metoprolol plus JNJ-54452840 | Experimental | Metoprolol tartrate immediate-release (metoprolol IR) will be administered as single oral dose of 100 milligram (mg) tablet or capsule. After two hours, placebo (normal saline) will be administered intravenously over 1 minute on Day 1. Receives: Drug: Metoprolol tartrate immediate-release (metoprolol IR); Drug: JNJ-54452840; Drug: Placebo |
| Metoprolol plus JNJ-54452840 then Metoprolol plus placebo | Experimental | Metoprolol IR will be administered as single oral dose of 100 mg tablet or capsule. After two hours, JNJ-54452840 (12 milliliter [ml] solution containing 240 mg JNJ-54452840) will be administered intravenously over 1 minute. Receives: Drug: Metoprolol tartrate immediate-release (metoprolol IR); Drug: JNJ-54452840; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Heart Rate
Heart rate will be measured during the last 10 seconds of each 3-minute upright bicycle ergometer exercise test in healthy participants.
Measured: Day 1 of Treatment Period 1
Exercise Heart Rate
Heart rate will be measured during the last 10 seconds of each 3-minute upright bicycle ergometer exercise test in healthy participants.
Measured: Day 1 of Treatment Period 2
Secondary outcomes (1)
Exercise Blood Pressure
Blood Pressure will be measured during the last 10 seconds of each 3-minute upright bicycle ergometer exercise test in healthy participants.
Measured: Day 1 of Treatment Period 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionOct 2013 (estimated)
- Study completionMay 2014 (estimated)
Why it stopped: Trial was stopped because study not required for development.
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
- 0 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
- NCT01902550
- Sponsor's protocol ID
- CR102301
- Other IDs
- 54452840HFA1002
- Status last verified
- Oct 2016
- First submitted
- 15 Jul 2013
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, 2-Period Crossover Study to Evaluate the Effect of Single Dose JNJ-54452840 on Pharmacodynamics of Metoprolol Tartrate Immediate-Release in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01902550
- Acronym / sponsor ID
- CR102301
- Conditions
- Healthy
- Keywords
- Healthy, JNJ-54452840, Metoprolol Tartrate Immediate-Release, Placebo, Male
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Trial was stopped because study not required for development.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Oct 2013 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 18 Jul 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 evaluate effect of co-administration of JNJ-54452840 and metoprolol tartrate immediate-release (metoprolol IR) compared to metoprolol IR alone on the exercise heart rate and blood pressure measured at the end of each 3-minute exercise test in healthy participants.
Detailed description
This is a Phase 1, randomized (the study drug is assigned by chance), single-center, double-blind (neither physician nor participant knows the treatment that the participant receives) and 2-period crossover (participants may receive different interventions sequentially during the trial) study of JNJ-54452840 and metoprolol tartrate in healthy participants. The duration of study will be up to 7 weeks per participant and up to 1 year for participants if they develop anti-beta 1-AR (adrenergic receptor) auto-antibodies (auto-antibodies targeting the human beta-1-AR, antibody is a type of protein that helps protect the body against foreign matter, such as bacteria and viruses). The study consists of 3 parts: Screening (that is, up to 14 days before study commences on Day 1); Treatment (consists of either metoprolol IR and JNJ-54452840 or metoprolol IR and Placebo for 8 days, in subsequent two-treatment periods, separated by wash-out period of 2-7 days); and Follow-up (that is, 7-10 days after last study dose for safety assessment; followed by another visit after 21-28 days of last study dose for assessment of anti beta-1-AR auto-antibodies in blood). Any potential interaction between JNJ-54452840 and metoprolol tartrate IR will primarily be evaluated by measuring exercise induced heart rate (that is, post exercise). Participants' safety will be monitored throughout the study. If beta-1-AR-auto-antibodies are detected at the follow up visit 21-28 days after last treatment period study procedure, additional testing will be performed every 3 months until auto-antibody levels fall below the level of detection of the assay or for 1 year, whichever occurs earlier.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metoprolol plus placebo then Metoprolol plus JNJ-54452840 | Experimental | Drug: Metoprolol tartrate immediate-release (metoprolol IR), Drug: JNJ-54452840, Drug: PlaceboMetoprolol tartrate immediate-release (metoprolol IR) will be administered as single oral dose of 100 milligram (mg) tablet or capsule. After two hours, placebo (normal saline) will be administered intravenously over 1 minute on Day 1. |
| Metoprolol plus JNJ-54452840 then Metoprolol plus placebo | Experimental | Drug: Metoprolol tartrate immediate-release (metoprolol IR), Drug: JNJ-54452840, Drug: PlaceboMetoprolol IR will be administered as single oral dose of 100 mg tablet or capsule. After two hours, JNJ-54452840 (12 milliliter [ml] solution containing 240 mg JNJ-54452840) will be administered intravenously over 1 minute. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Be a healthy non-smoking male with no clinically relevant abnormalities
- Able to perform upright bicycle ergometer exercise test and be able to achieve greater than or equal to 80 percent of maximum heart rate (HR) determined as (220 beats per minute [bpm]-age) during the last 10 seconds of the 3rd minute of exercise test
- Agree to abstain from caffeine (example, coffee, tea, chocolate, or caffeine-containing soft drinks) intake during the inpatient portion of the study
- Participants with body mass index between 18 and 32 kilogram per square meter (kg/m^2) and body weight greater than or equal to 50 kilogram (Kg) at screening
Key exclusion criteria (6 listed)
- Contraindication to metoprolol tartrate immediate release (metoprolol IR)
- Resting HR less than 50 bpm and blood pressure less than 110/70 millimeter of mercury (mmHg)
- Physical disability that would preclude safe and adequate exercise test performance
- History of or current clinically significant medical illness that the Investigator considers should exclude the subject or that could interfere with the interpretation of the study results
- Determined to have variant cytochrome P4502D6 (CYP2D6) alleles encoding for altered metabolism
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 |
|---|---|---|
| Metoprolol tartrate immediate-release (metoprolol IR)Metoprolol IR will be administered as single oral dose of 100 mg tablet or capsule. | Drug | Metoprolol plus JNJ-54452840 then Metoprolol plus placebo, Metoprolol plus placebo then Metoprolol plus JNJ-54452840 |
| JNJ-54452840JNJ-54452840 (12 ml solution containing 240 mg JNJ-54452840) will be administered intravenously over 1 minute. | Drug | Metoprolol plus JNJ-54452840 then Metoprolol plus placebo, Metoprolol plus placebo then Metoprolol plus JNJ-54452840 |
| PlaceboMatching Placebo (normal saline) to JNJ-54452840 will be administered intravenously over 1 minute on Day 1. | Drug | Metoprolol plus JNJ-54452840 then Metoprolol plus placebo, Metoprolol plus placebo then Metoprolol plus JNJ-54452840 |
Primary outcome
Exercise Heart Rate
Time frame: Day 1 of Treatment Period 1
Heart rate will be measured during the last 10 seconds of each 3-minute upright bicycle ergometer exercise test in healthy participants.
Exercise Heart Rate
Time frame: Day 1 of Treatment Period 2
Heart rate will be measured during the last 10 seconds of each 3-minute upright bicycle ergometer exercise test in healthy participants.
1 secondary outcome
Exercise Blood Pressure
Time frame: Day 1 of Treatment Period 1 and 2
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 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
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 Metoprolol tartrate immediate-release (metoprolol IR) and 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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 1 Nov 2016. 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
Exercise Heart Rate (time frame: Day 1 of Treatment Period 1). 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 1 Nov 2016.