Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-56136379 · 5 trials · 4 indications
Change from baseline in HBsAg levels in currently not treated population at Week 24 based on Hepatitis B e Antigen (HBeAg) status was reported. Currently not treated population defined as participants who didn't receive any hepatitis B virus (HBV) treatment 6 months prior to baseline.
Change from baseline in HBsAg levels in virologically suppressed population at Week 24 based on HBeAg status was reported. Virologically suppressed population defined as participants who were on entecavir (ETV) or tenofovir disoproxil fumarate (TDF) for at least 12 months prior to screening and had HBV deoxyribonucleic acid (DNA) \<60 IU/mL. This outcome measure was planned to be analyzed for specified arms only.
Plasma concentration of oral dose of JNJ-56136379 will be assessed.
AUC \[0-72 hours\] is defined as area under the plasma analyte concentration versus time curve from time 0 to 72 hours postdose.
AUC \[0-72 hours\] is defined as area under the plasma analyte concentration versus time curve from time 0 to 72 hours postdose.
AUC \[0-408 hours\] is defined as area under the plasma analyte concentration versus time curve from time 0 to 408 hours postdose.
AUC \[0-408 hours\] is defined as area under the plasma analyte concentration versus time curve from time 0 to 408 hours postdose.
Cmax is defined as maximum observed plasma analyte concentration.
Cmax is defined as maximum observed plasma analyte concentration.
The Cmax is the maximum observed plasma concentration.
The Tmax is defined as actual sampling time to reach maximum observed plasma analyte concentration.
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.
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.
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.
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.
Physical examinations (including body weight measurement and skin examination) will be performed.
Physical examinations (including body weight measurement and skin examination) will be performed.
Vital signs (Supine Blood Pressure \[SBP\], Diastolic Blood Pressure \[DBP\] pulse rate: supine and standing) will be performed.
Vital signs (SBP, DBP pulse rate: supine and standing) will be performed.
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.
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.
Cmax is the Maximum observed plasma concentration.
Cmax is the Maximum observed plasma concentration.
Cmax is the Maximum observed plasma concentration.
AUClast is the area under the curve from time 0 to the time of the last measurable Concentration.
AUClast is the area under the curve from time 0 to the time of the last measurable Concentration.
AUC infinity is the area under the curve from time 0 to infinity.
AUC infinity is the area under the curve from time 0 to infinity.
| Arm | Type | Description |
|---|---|---|
| Part A: Arm 1 (JNJ-56136379 or NA) (open label) | EXPERIMENTAL | Participants with hepatitis B virus (HBV) currently not being treated and receiving JNJ-56136379 tablet (at a lower dose) orally for 24 weeks, will stop further dosing with JNJ-56136379 and start treatment with nucleos(t)ide analog (NA) (entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\]), and enter the 24 week post treatment follow-up phase. |
| Part A: Arm 2 (Placebo+NA [ETV] or [TDF]) | PLACEBO_COMPARATOR | Participants with HBV currently not being treated will receive matching placebo along with NA (ETV or TDF) tablets orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks. |
| Part A: Arm 3 (JNJ-56136379 + NA [ETV or TDF]) | EXPERIMENTAL | Participants with HBV currently not being treated will receive JNJ-56136379 along with NA (ETV or TDF) tablet orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks. |
| Part A: Arm 4 (Placebo + NA [ETV or TDF]) | PLACEBO_COMPARATOR | Virologically suppressed participants will receive matching placebo along with NA (ETV or TDF) tablets orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks. |
| Part A: Arm 5 (JNJ-56136379 + NA [ETV or TDF]) | EXPERIMENTAL | Virologically suppressed participants will receive JNJ-56136379 along with NA (ETV or TDF) tablets orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks. |
| Part B: Arm 6 (JNJ-56136379 + NA [ETV or TDF]) (open label) | EXPERIMENTAL | Participants with HBV currently not being treated will receive JNJ-56136379 tablet at a high dose, orally for 24 weeks. The eligible participants may enter the extension phase and will receive JNJ-56136379 along with NA (ETV or TDF) from Week 24 to Week 48. |
| Part B: Arm 7 (placebo + NA [ETV or TDF]) | PLACEBO_COMPARATOR | Participants with HBV currently not being treated will receive matching placebo along with NA (ETV or TDF) tablets orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks. |
| Part B: Arm 8 (JNJ-56136379 + NA [ETV or TDF]) | EXPERIMENTAL | Participants with HBV currently not being treated will receive JNJ-56136379 tablet at a high dose along with NA (ETV or TDF) tablets orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks. |
| Part B: Arm 9 (placebo + NA [ETV or TDF]) | PLACEBO_COMPARATOR | Virologically suppressed participants will receive matching placebo along with NA (ETV or TDF) tablets orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks. |
| Part B: Arm 10 (JNJ-56136379 + NA [ETV or TDF]) | EXPERIMENTAL | Virologically suppressed participants will receive JNJ-56136379 tablet at a high dose along with NA (ETV or TDF) tablets orally for 24 weeks. The eligible participants may enter the extension phase and will continue study drugs up to 48 weeks. |
| Part A: Group 1 | EXPERIMENTAL | Participants with liver cirrhosis with moderate hepatic impairment will receive a single oral dose of JNJ-56136379 in fed condition. |
| Part A: Group 2 | EXPERIMENTAL | Participants with normal liver function with no liver cirrhosis will receive a single oral dose of JNJ-56136379 in fed condition. |
| Part B: Group 3 (optional) | EXPERIMENTAL | Participants with liver cirrhosis with mild hepatic impairment will receive a single oral dose of JNJ-56136379 in fed condition. |
| Part B: Group 4 (optional) | EXPERIMENTAL | Participants with liver cirrhosis with severe hepatic impairment will receive a single oral dose of JNJ-56136379 in fed condition. |
| JNJ-56136379 and Itraconazole | EXPERIMENTAL | Participants will receive a single dose of JNJ-56136379 on Day 1 in Treatment Period 1 and itraconazole 200 mg once daily for 21 days starting on Day 34 along with a single dose of JNJ 56136379 on Day 38 in Treatment Period 2. JNJ-56136379 intake in Treatment Period 1 and the first intake of itraconazole in Treatment Period 2 will be separated by a washout period of at least 33 days. Study drug (JNJ-56136379 and itraconazole) intakes will be taken orally and under fed conditions. |
| 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. |
| 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. |
| 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. |
| 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. |
| Part 1: Single Dose Escalation | EXPERIMENTAL | The 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. |
| Part 1: Multiple dose session | EXPERIMENTAL | After 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. |
| Part 2: Multiple dose escalation | EXPERIMENTAL | Multiple 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. |
| Name | Type | Description |
|---|---|---|
| JNJ-56136379 | DRUG | Participants will receive JNJ-56136379 tablet orally. |
| Placebo | DRUG | Participants will receive matching placebo tablet orally. |
| NA (ETV or TDF) | DRUG | Participants will receive NA (ETV or TDF) tablet orally as per approved label. |
| Itraconazole | DRUG | Participants will receive 200 mg of itraconazole once daily orally for 21 days starting on Day 34. |
Inclusion Criteria: * Participants must have a body mass index (weight in kilogram (kg) divided by the square of height in meters) of 18.0 to 35.0 kilogram / square meter (kg/m\^2), extremes included * Participants must have chronic hepatitis B virus infection (CHB) infection documented by: Serum h...
JNJ-56136379 is an investigational small molecule being studied for the treatment of chronic hepatitis B virus infection. It has also been evaluated in clinical trials involving healthy participants and individuals with hepatic impairment. The drug is administered orally and is currently in clinical development.
JNJ-56136379 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker symbol JNJ. The drug is an investigational small molecule candidate in the company's pipeline.
JNJ-56136379 has completed Phase 1 and Phase 2 clinical trials. All three completed trials were controlled and double-blinded, with a total enrollment of 232 participants across the studies. The drug remains investigational and has not been approved by regulatory authorities.
JNJ-56136379 has been studied in three completed clinical trials. NCT02662712 evaluated safety and pharmacokinetics in healthy participants and those with chronic hepatitis B. NCT02933580 studied the drug in healthy Japanese adults. NCT03361956 assessed efficacy and safety in participants with chronic hepatitis B virus infection.
JNJ-56136379 is the primary name used for this investigational drug in clinical trial registrations. No alternative names have been associated with this compound in the available clinical trial information.