Clinical trial NCT02662712 (phase 1, status: completed)
Conditions: healthy, hepatitis, chronic
ICD codes: Z76.3, Z76.2
Drugs: jnj-56136379, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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