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HealthyPhase 1NCT02662712

A Study of Orally Administered JNJ-56136379 to Evaluate Safety, Tolerability and Pharmacokinetics After Single Ascending Doses and One Multiple Dose Regimen in Healthy Participants (Part I), and After Multiple Dose Regimens in Participants With Chronic Hepatitis B (Part II)

A Phase 1 study testing JNJ-56136379 in people with Healthy and Hepatitis, Chronic, run by Janssen Sciences Ireland UC at 27 sites in 10 countries.

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

The purpose of this study is to evaluate pharmacokinetics and safety data including serious and other adverse events, physical examinations, vital signs, 12-lead electrocardiograms (ECGs) and clinical laboratory results (including biochemistry, hematology, and urine). Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy, Hepatitis, Chronic
What is being tested?
JNJ-56136379
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
87 participants
Where
27 sitesin 10 countries
Study dates
17 Dec 2015to 29 Jun 2018
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • For Part II, a female participant must be either of a) Non-childbearing potential defined as: 1) Postmenopausal: A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level (greater than (>)40 international unit per milliliter (IU/L) or milli-international units per milliliter (mIU/mL) in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy, however in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient, or 2) Permanently sterile: Permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy, or b) Childbearing potential and practicing sexual abstinence or a highly effective method of contraception from screening onwards and agree to continue to use the same method of contraception throughout study treatment and for at least 90 days after the last dose of study drug (or longer, if dictated by local regulation)
  • Female participants should have a negative serum pregnancy test at screening
  • Healthy Participants: Participants must have a body mass index (BMI; weight in kg divided by the square of height in meters) of 18.0 to 30.0 kilogram per square meter (kg/m2), extremes included
  • Chronic Hepatitis B Participants: Participants must have lack of advanced liver disease, ie, either: Metavir F0-F2 (or comparable histologic scoring system) as determined on a liver biopsy within one year of the screening visit; a result based on specific radiologic liver disease staging modalities (eg, Fibroscan, AFRI, magnetic resonance imaging [MRI]-Elastography) compatible with Metavir F0-F2 within 6 months of the screening visit
  • Chronic Hepatitis B Participants: Participants must have HBV DNA of greater than or equal [>=] 2,000 international unit per milliliter (IU/mL) at screening
  • Chronic Hepatitis B Participants: Participants must be aged between 18 years to 65 years, have a body mass index (BMI; weight in kg divided by the square of height in meters) of 18.0 to 35.0 kilogram per square meter (kg/m^2), extremes included

Who cannot join

  • Healthy Participants: Participants with a past history of cardiac arrhythmias (example, extrasystolic, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (eg, hypokalemia, family history of long QT Syndrome)
  • Healthy Participants: Female participants who are breastfeeding at screening
  • Healthy Participants: Participants with current human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection (confirmed by antibodies) at screening
  • Chronic Hepatitis B Participants: Participants with current HCV infection (confirmed by HCV antibody or HCV RNA) or hepatitis delta virus (HDV) infection (confirmed by HDV antibody) at screening
  • Chronic Hepatitis B Participants: Participants with positivity of anti-HBs antibodies
  • Chronic Hepatitis B Participants: Participants with a past history of cardiac arrhythmias (eg, extrasystolic, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (eg, hypokalemia, family history of long QT Syndrome)
  • Chronic Hepatitis B Participants: Female participants who are breastfeeding at screening

Trial locations and contacts

27 sites in 10 countries.

27 sites in 10 countries

Spain5 sites

  • Study site

    Barcelona

  • Study site

    Madrid

  • Study site

    Santander

  • Study site

    Seville

  • Study site

    Valencia

Other trials in Spain

Taiwan5 sites

  • Study site

    Kaohsiung City

  • Study site

    Keelung

  • Study site

    Taichung

  • Study site

    Taipei

  • Study site

    Taoyuan

Other trials in Taiwan

Belgium4 sites

  • Study site

    Brussels

  • Study site

    Edegem

  • Study site

    Mechelen

  • Study site

    Merksem

Other trials in Belgium

France4 sites

  • Study site

    Clichy

  • Study site

    La Tronche

  • Study site

    Lyon

  • Study site

    Paris

Other trials in France

Germany3 sites

  • Study site

    Essen

  • Study site

    Hanover

  • Study site

    Wiesbaden

Other trials in Germany

Romania2 sites

  • Study site

    Bucharest

  • Study site

    Timișoara

Other trials in Romania

Bulgaria1 site

  • Study site

    Sofia

Other trials in Bulgaria

Georgia1 site

  • Study site

    Tbilisi

Other trials in Georgia

Malaysia1 site

  • Study site

    Kuala Lumpur

Other trials in Malaysia

Moldova1 site

  • Study site

    Chisinau

Other trials in Moldova

About this study

Official title: A Phase 1, Double-blind, Randomized, Placebo-controlled, First-in-human Study of Orally Administered JNJ-56136379 to Evaluate Safety, Tolerability and Pharmacokinetics After Single Ascending Doses and One Multiple Dose Regimen in Healthy Subjects (Part I), and After Multiple Dose Regimens in Subjects With Chronic Hepatitis B (Part II)

The purpose of this study is to evaluate pharmacokinetics and safety data including serious and other adverse events, physical examinations, vital signs, 12-lead electrocardiograms (ECGs) and clinical laboratory results (including biochemistry, hematology, and urine).

Read the detailed description

Part 1: This is a first-in-human (FIH), double-blind (neither the researchers nor the participants know what treatment the participant is receiving), randomized (study medication assigned to participants by chance), placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect) study. Part 1 includes healthy adult participants, divided into 3 panels (Panel 1, 2 and 3) and in Part 2 adult Chronic Hepatitis B Participants will be included, in Sessions VIII to XI and Optional Sessions A-B-C (Panel 4). The study will consists of screening phase (part 1: [less than or equal to <=28 days before the first intake of study drug; part 2: [<=56 to greater than or equal to {>=} 20 days before the first intake of study drug), Treatment Phase (multiple dose phase in part 1: Day -1 up to 12 or 19 days; part 2: up to 4 weeks) and Follow up Phase (part 1: 30-35 days after last study drug intake or after dropout; part 2: up to week 8 after actual end of study drug treatment). Participants' safety will be evaluated throughout the study.

Being tested
JNJ-56136379, Placebo
Keywords
Healthy, Hepatitis, Chronic, JNJ-56136379, Placebo
Medical subject headings
Hepatitis, Chronic

What participants receive

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

  • JNJ-56136379Drug

    JNJ-56136379 oral tablets will be given in Part 1 (single dose escalation and multiple dose session) and Part 2 (multiple dose escalation).

  • PlaceboDrug

    Matching placebo to JNJ-56136379 will be given in Part 1 (single dose escalation and multiple dose session) and Part 2 (multiple dose escalation).

Study groups in NCT02662712
Study groupRoleWhat they receive
Part 1: Single Dose EscalationExperimentalThe single dose escalation phase of the study will consist of 6 dosing sessions (Sessions I to VI) evaluated in 2 panels (Panels 1 and 2). The dose of JNJ-56136379 will be consecutively escalated over 5 levels, alternating between the 2 panels. Panel 1 will receive 3 single doses (SD1, SD3 and SD3fed) in Sessions I, III and V, respectively. Panel 2 will receive 3 single doses (SD2, SD4 and SD5) in Sessions II, IV and VI, respectively. There will be a washout period of at least 14 days between consecutive JNJ-56136379/placebo dosing in each individual participant.
Receives: Drug: JNJ-56136379; Drug: Placebo
Part 1: Multiple dose sessionExperimentalAfter completion of the fifth single dose session another panel of healthy participant (panel 3) receive multiple doses of JNJ-56136379 at one dose level (MDx) or placebo for 12 or 19 consecutive days (Session VII) in fed or fasted conditions.
Receives: Drug: JNJ-56136379; Drug: Placebo
Part 2: Multiple dose escalationExperimentalMultiple dose levels will be given in Panel 4 in Session VIII (European sites), Sessions IX and X (European and/or Asian sites) Session XI (Asian sites) for 28 consecutive days in fed conditions. Optional Sessions A-B-C (Panel 4) used for further dose evaluations at European and/or Asian sites. Per session, participants will receive JNJ 56136379 or placebo. Dose progression to the next multiple dose level may be adapted based on the emerging safety and PK outcome of the previous dosing levels.
Receives: Drug: JNJ-56136379; Drug: Placebo

What is being measured

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

  1. Part 1 Single Ascending Dose and Multiple Dose : Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events

    An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

    Measured: Until the last study-related activity (30-35 days after last dosing)

  2. Part 2: Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events

    An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

    Measured: Up to Week 12

  3. Part 1 Single Ascending Dose and Multiple Dose : Number of Participants With Abnormal Physical Examinations

    Physical examinations (including body weight measurement and skin examination) will be performed.

    Measured: 30-35 days after last study drug intake or after dropout

  4. Part 2: Number of Participants With Abnormal Physical Examinations

    Physical examinations (including body weight measurement and skin examination) will be performed.

    Measured: Up to Week 8

  5. Part 1 Single Ascending Dose and Multiple Dose : Number of Participants With Abnormal Vital Signs

    Vital signs (Supine Blood Pressure [SBP], Diastolic Blood Pressure [DBP] pulse rate: supine and standing) will be performed.

    Measured: 30-35 days after last study drug intake or after dropout

  6. Part 2: Number of Participants With Abnormal Vital Signs

    Vital signs (SBP, DBP pulse rate: supine and standing) will be performed.

    Measured: Up to Week 8

  7. Part 1 Single Ascending Dose and Multiple Dose : Number of Participants With Clinically Significant Laboratory Findings

    The laboratory abnormalities will be determined according to the criteria specified in the World Health Organization (WHO) Toxicity Grading Scale and in accordance with the normal ranges of the clinical laboratory.

    Measured: 30-35 days after last study drug intake or after dropout

  8. Part 2: Number of Participants With Clinically Significant Laboratory Findings

    The laboratory abnormalities will be determined according to the criteria specified in the World Health Organization (WHO) Toxicity Grading Scale and in accordance with the normal ranges of the clinical laboratory.

    Measured: Up to Week 8

  9. Part 1: Maximum Observed Plasma Concentration (Cmax) After Single Dose Administration

    Cmax is the Maximum observed plasma concentration.

    Measured: Pre-dose, 0.5 hour (hr), 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hr post-dose on Day 1

  10. Part 1: Maximum Observed Plasma Concentration (Cmax) After Multiple Dose Administration

    Cmax is the Maximum observed plasma concentration.

    Measured: Pre-dose, 0.5 hr, 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hr Day 1; post-dose on Day 12

  11. Part 2: Maximum Observed Plasma Concentration (Cmax)

    Cmax is the Maximum observed plasma concentration.

    Measured: Pre-dose, 8, 12 hr post-dose on Day 1; post-dose on Day 28

  12. Part 1: Area Under the Curve From Time 0 to the Time of the Last Measurable Concentration (AUClast) After Single Dose Administration

    AUClast is the area under the curve from time 0 to the time of the last measurable Concentration.

    Measured: Pre-dose, 0.5 hour (hr), 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hr post-dose on Day 1

  13. Part 2: Area Under the Curve From Time 0 to the Time of the Last Measurable Concentration (AUClast)

    AUClast is the area under the curve from time 0 to the time of the last measurable Concentration.

    Measured: Pre-dose, 8, 12 hr post-dose on Day 1; post-dose on Day 28

  14. Part 1: Area Under the Curve From Time 0 to Infinity (AUC infinity) After Single Dose Administration

    AUC infinity is the area under the curve from time 0 to infinity.

    Measured: Pre-dose, 0.5 hour (hr), 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hr post-dose on Day 1

  15. Part 2: Area Under the Curve From Time 0 to Infinity (AUC infinity)

    AUC infinity is the area under the curve from time 0 to infinity.

    Measured: Pre-dose, 8, 12 hr post-dose on Day 1; post-dose on Day 28

Secondary outcomes (5)

  1. Part 2: Change From Baseline in Mean Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA)

    HBV DNA will be quantified using an in vitro nucleic acid amplification test for the quantification of HBV DNA.

    Measured: Up to week 12

  2. Part 2: Maximum Decrease in HBV DNA (Baseline-subtracted Mean)

    HBV DNA will be quantified using an in vitro nucleic acid amplification test for the quantification of HBV DNA.

    Measured: Up to week 12

  3. Part 2: Changes in Hepatitis B Surface Antigen (HBsAg) Levels

    Quantitative HBsAg and levels will be determined from samples using standard serologic assays.

    Measured: Up to week 12

  4. Part II: Percentage of Participants with Treatment Emerging Mutations

    Treatment induced emerging mutations will be assessed by comparing the HBV genome sequence obtained at baseline with sequences obtained post-baseline.

    Measured: Up to week 12

  5. Part II: Change From Baseline in HBV DNA (Antiviral Activity) in Chronic Hepatitis B (CHB) Participants with Sequence Variations in the HBV Genome

    Sequence variations in the HBV genome will be assessed by sequencing of the viral genome. Antiviral activity will be assessed by measuring change from baseline in HBV DNA concentration using in vitro nucleic acid amplification test for the quantification of HBV DNA and compared between participants with and without HBV sequence variations.

    Measured: Up to week 12

Timeline

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

  1. First posted25 Jan 2016 (estimated)
  2. Study start17 Dec 2015
  3. Primary completion29 Jun 2018
  4. Study completion29 Jun 2018

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
87 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02662712
Sponsor's protocol ID
CR108092
Other IDs
56136379HPB1001, 2015-003724-30, 2015
Status last verified
Jan 2025
First submitted
2 Dec 2015
Last updated
3 Feb 2025
Results posted
No
FDA-regulated device
No

Publications

  • Zoulim F, Lenz O, Vandenbossche JJ, Talloen W, Verbinnen T, Moscalu I, Streinu-Cercel A, Bourgeois S, Buti M, Crespo J, Manuel Pascasio J, Sarrazin C, Vanwolleghem T, Shukla U, Fry J, Yogaratnam JZ. JNJ-56136379, an HBV Capsid Assembly Modulator, Is Well-Tolerated and Has Antiviral Activity in a Phase 1 Study of Patients With Chronic Infection. Gastroenterology. 2020 Aug;159(2):521-533.e9. doi: 10.1053/j.gastro.2020.04.036. Epub 2020 Apr 25.

    PubMed 32343960

  • Vandenbossche J, Jessner W, van den Boer M, Biewenga J, Berke JM, Talloen W, De Zwart L, Snoeys J, Yogaratnam J. Pharmacokinetics, Safety and Tolerability of JNJ-56136379, a Novel Hepatitis B Virus Capsid Assembly Modulator, in Healthy Subjects. Adv Ther. 2019 Sep;36(9):2450-2462. doi: 10.1007/s12325-019-01017-1. Epub 2019 Jul 2.

    PubMed 31267367

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-56136379 in people with Healthy and Hepatitis, Chronic, run by Janssen Sciences Ireland UC at 27 sites in 10 countries.

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 6 inclusion and 7 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 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Spain, Taiwan, Belgium, France, Germany and 5 more countries. 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?

Part 1 Single Ascending Dose and Multiple Dose : Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events (time frame: Until the last study-related activity (30-35 days after last dosing)). The study lists 15 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 NCT02662712, which also lists 2 linked publications.

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 3 Feb 2025.

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