HealthyPhase 1NCT02933580
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of JNJ-56136379 in Healthy Japanese Adult Participants
A Phase 1 study testing JNJ-56136379 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 investigate the safety, tolerability, and pharmacokinetics (PK) of JNJ-56136379 in healthy Japanese adult participants following oral administration of single doses from 25 milligram (mg) up to 600 mg, in fasted conditions. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- JNJ-56136379
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2016to 4 Feb 2017
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant must be a Japanese participant who has resided outside Japan for no more than 10 years and whose parents and grandparents are Japanese as determined by participant's verbal report
- Participant must be healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination, medical and surgical history, vital signs, and the results of blood biochemistry, blood coagulation, and hematology tests and a urinalysis performed at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed/signed by the investigator
- Participant must have a body mass index (BMI; weight in kilogram [kg] divided by the square of height in meters) of 18.0 to 30.0 kilogram per meter square [kg/m^2], extremes inclusive, and body weight not less than 45.0 kg
- Participant must have a normal 12-lead electrocardiogram (ECG) (based on the mean value of the triplicate parameters) at screening including: normal sinus rhythm (heart rate between 45 and 100 beats per minute [bpm], extremes included); QT interval corrected for heart rate according to Fridericia (QTcF) less than or equal to (<=)450 millisecond (ms); QRS interval less than (<)120 ms; PR interval <=220 ms
- A female participant (except if permanently sterile), should have a negative serum pregnancy test at screening and all female participants should have a negative urine pregnancy test on Day -1
Who cannot join
- Participant with a past history of cardiac arrhythmias (example [eg], extrasystoli, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (eg, hypokalemia, family history of long QT Syndrome)
- Female participant who is breastfeeding at screening or pregnant at screening or predose
- Male participant planning to father a child while enrolled in this study or within 90 days after study drug administration
- Participant with current human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection (confirmed by antibodies) at Screening
- Participant with current hepatitis A infection (confirmed by hepatitis A antibody immunoglobulin M [IgM]), or hepatitis B virus (HBV) infection (confirmed by HBsAg), or hepatitis C virus (HCV) infection (confirmed by HCV antibody), or hepatitis E infection (confirmed by hepatitis E antibody IgM) at Screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Placebo-controlled, Randomized, Phase 1, Single Ascending Dose Study to Investigate Safety, Tolerability, and Pharmacokinetics of JNJ-56136379 in Healthy Japanese Adult Subjects
The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics (PK) of JNJ-56136379 in healthy Japanese adult participants following oral administration of single doses from 25 milligram (mg) up to 600 mg, in fasted conditions.
- Conditions
- Healthy
- Being tested
- JNJ-56136379, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-56136379Drug
Participants will receive a single oral dose (tablets) of JNJ-56136379 on Day 1.
PlaceboOther
Participants will receive matching placebo tablets on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: JNJ-56136379 (25 mg) or Placebo | Experimental | Participants will receive a single oral dose of 25 milligram (mg) of JNJ-56136379 (1*25-mg tablet) or placebo on Day 1, fasted conditions. Receives: Drug: JNJ-56136379; Other: Placebo |
| Cohort B: JNJ-56136379 (150 mg) or Placebo | Experimental | Participants will receive a single oral dose of 150 mg of JNJ-56136379 (2* 25-mg tablet and 1*100-mg tablet) or placebo on Day 1, fasted conditions. Receives: Drug: JNJ-56136379; Other: Placebo |
| Cohort C: JNJ-56136379 (300 mg) or Placebo | Experimental | Participants will receive a single oral dose of 300 mg of JNJ-56136379 (3*100-mg tablet) or placebo on Day 1, fasted conditions. Receives: Drug: JNJ-56136379; Other: Placebo |
| Cohort D: JNJ-56136379 (600 mg) or Placebo | Experimental | Participants will receive a single oral dose of 600 mg of JNJ-56136379 (6*100-mg tablet) or placebo on Day 1, fasted conditions. Receives: Drug: JNJ-56136379; Other: Placebo |
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.
Measured: Up to 29 days
Time to Reach Maximum Observed Plasma Concentration (Tmax)
The Tmax is defined as actual sampling time to reach maximum observed plasma analyte concentration.
Measured: Up to 29 days
Area Under the Concentration-Time Curve from time 0 to the Time of the Last Measurable non-Below Quantification Limit Concentration (AUC [0-last])
AUC (0-last) is defined as area under the analyte concentration-time curve from time 0 to the time of the last measurable (non-below quantification limit [BQL]) concentration, calculated by linear-linear trapezoidal summation.
Measured: Up to 29 days
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last observed measurable (non-BQL) concentration, and lambda(z) is elimination rate constant; extrapolations of more than 20.00 percent (%) of the total AUC are reported as approximations.
Measured: Up to 29 days
Number of Participants With Adverse events as a Measure of Safety and Tolerability
Measured: 30-35 days after study drug intake (approximately 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study start12 Oct 2016
- Primary completion4 Feb 2017
- Study completion4 Feb 2017
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
- 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
- NCT02933580
- Sponsor's protocol ID
- CR108247
- Other IDs
- 56136379HPB1003
- Status last verified
- Mar 2018
- First submitted
- 12 Oct 2016
- Last updated
- 16 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Randomized, Phase 1, Single Ascending Dose Study to Investigate Safety, Tolerability, and Pharmacokinetics of JNJ-56136379 in Healthy Japanese Adult Subjects
- ClinicalTrials.gov ID
- NCT02933580
- Acronym / sponsor ID
- CR108247
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2016 (actual)
- Primary completion
- 4 Feb 2017 (actual)
- Study completion
- 4 Feb 2017 (actual)
- First posted
- 14 Oct 2016 (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 investigate the safety, tolerability, and pharmacokinetics (PK) of JNJ-56136379 in healthy Japanese adult participants following oral administration of single doses from 25 milligram (mg) up to 600 mg, in fasted conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A: JNJ-56136379 (25 mg) or Placebo | Experimental | Drug: JNJ-56136379, Other: PlaceboParticipants will receive a single oral dose of 25 milligram (mg) of JNJ-56136379 (1*25-mg tablet) or placebo on Day 1, fasted conditions. |
| Cohort B: JNJ-56136379 (150 mg) or Placebo | Experimental | Drug: JNJ-56136379, Other: PlaceboParticipants will receive a single oral dose of 150 mg of JNJ-56136379 (2* 25-mg tablet and 1*100-mg tablet) or placebo on Day 1, fasted conditions. |
| Cohort C: JNJ-56136379 (300 mg) or Placebo | Experimental | Drug: JNJ-56136379, Other: PlaceboParticipants will receive a single oral dose of 300 mg of JNJ-56136379 (3*100-mg tablet) or placebo on Day 1, fasted conditions. |
| Cohort D: JNJ-56136379 (600 mg) or Placebo | Experimental | Drug: JNJ-56136379, Other: PlaceboParticipants will receive a single oral dose of 600 mg of JNJ-56136379 (6*100-mg tablet) or placebo on Day 1, fasted conditions. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participant must be a Japanese participant who has resided outside Japan for no more than 10 years and whose parents and grandparents are Japanese as determined by participant's verbal report
- Participant must be healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination, medical and surgical history, vital signs, and the results of blood biochemistry, blood coagulation, and hematology tests and a urinalysis performed at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed/signed by the investigator
- Participant must have a body mass index (BMI; weight in kilogram [kg] divided by the square of height in meters) of 18.0 to 30.0 kilogram per meter square [kg/m^2], extremes inclusive, and body weight not less than 45.0 kg
- Participant must have a normal 12-lead electrocardiogram (ECG) (based on the mean value of the triplicate parameters) at screening including: normal sinus rhythm (heart rate between 45 and 100 beats per minute [bpm], extremes included); QT interval corrected for heart rate according to Fridericia (QTcF) less than or equal to (<=)450 millisecond (ms); QRS interval less than (<)120 ms; PR interval <=220 ms
- A female participant (except if permanently sterile), should have a negative serum pregnancy test at screening and all female participants should have a negative urine pregnancy test on Day -1
Key exclusion criteria (5 listed)
- Participant with a past history of cardiac arrhythmias (example [eg], extrasystoli, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (eg, hypokalemia, family history of long QT Syndrome)
- Female participant who is breastfeeding at screening or pregnant at screening or predose
- Male participant planning to father a child while enrolled in this study or within 90 days after study drug administration
- Participant with current human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection (confirmed by antibodies) at Screening
- Participant with current hepatitis A infection (confirmed by hepatitis A antibody immunoglobulin M [IgM]), or hepatitis B virus (HBV) infection (confirmed by HBsAg), or hepatitis C virus (HCV) infection (confirmed by HCV antibody), or hepatitis E infection (confirmed by hepatitis E antibody IgM) at 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 |
|---|---|---|
| JNJ-56136379Participants will receive a single oral dose (tablets) of JNJ-56136379 on Day 1. | Drug | Cohort A: JNJ-56136379 (25 mg) or Placebo, Cohort B: JNJ-56136379 (150 mg) or Placebo, Cohort C: JNJ-56136379 (300 mg) or Placebo, Cohort D: JNJ-56136379 (600 mg) or Placebo |
| PlaceboParticipants will receive matching placebo tablets on Day 1. | Other | Cohort A: JNJ-56136379 (25 mg) or Placebo, Cohort B: JNJ-56136379 (150 mg) or Placebo, Cohort C: JNJ-56136379 (300 mg) or Placebo, Cohort D: JNJ-56136379 (600 mg) or Placebo |
Primary outcome
Maximum Observed Plasma Concentration (Cmax)
Time frame: Up to 29 days
The Cmax is the maximum observed plasma concentration.
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Up to 29 days
The Tmax is defined as actual sampling time to reach maximum observed plasma analyte concentration.
Area Under the Concentration-Time Curve from time 0 to the Time of the Last Measurable non-Below Quantification Limit Concentration (AUC [0-last])
Time frame: Up to 29 days
AUC (0-last) is defined as area under the analyte concentration-time curve from time 0 to the time of the last measurable (non-below quantification limit [BQL]) concentration, calculated by linear-linear trapezoidal summation.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
Time frame: Up to 29 days
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last observed measurable (non-BQL) concentration, and lambda(z) is elimination rate constant; extrapolations of more than 20.00 percent (%) of the total AUC are reported as approximations.
Number of Participants With Adverse events as a Measure of Safety and Tolerability
Time frame: 30-35 days after study drug intake (approximately 8 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 16 Mar 2018.
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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-56136379 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 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 16 Mar 2018. 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 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: Up to 29 days). The study lists 5 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 16 Mar 2018.