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| ID | Type | Description | Link |
|---|---|---|---|
| 64457744HPB1001 | Other Identifier | Janssen Research & Development, LLC |
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Strategic business decision, not due to safety concerns
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The purpose of the study is to evaluate the safety and tolerability of: single ascending dose (SAD) and multiple ascending dose (MAD) administration of JNJ-64457744, administered to healthy adult participants (Part 1 and Part 3), including a cohort of Asian participants (Part 1); and after single dose administration of JNJ-64457744 to chronic hepatitis B (CHB) participants who are virologically suppressed on nucleos(t)ide analog (NA) treatment (tenofovir disoproxil fumarate [TDF], tenofovir alafenamide [TAF], or entecavir [ETV]) (Part 2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: JNJ-64457744 or Placebo (Single Ascending Dose [SAD] Cohorts A-F) | Experimental | Non-Asian healthy participants will receive a SAD of either JNJ-64457744 or matching placebo as an oral formulation under fasted conditions on Day 1. Cohort F will be optional. |
|
| Part 1: JNJ-64457744 (Cohorts G-H) | Experimental | Non-Asian healthy participants will receive 3 single doses of JNJ-64457744 as an oral formulation in 3 intervention periods (to assess inter-subject PK-PD) matching the doses evaluated in Cohorts A, C and E for Cohort G and Cohorts B, D and F for Cohort H, under fasted conditions on Day 1. Cohort H will be optional for Intervention period 3. |
|
| Part 1: JNJ-64457744 or Placebo (Cohort I) | Experimental | Non-Asian healthy participants who previously received study intervention under fasted conditions will receive either JNJ-64457744 or matching placebo as an oral formulation (depending upon what was administered previously in Cohorts A to F) under fed conditions on Day 1. |
|
| Part 1: JNJ-64457744 or Placebo (Cohort J) | Experimental | Asian healthy participants will receive a single dose at one single dose level of either JNJ-64457744 or matching placebo, as an oral formulation, under fasted conditions on Day 1. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-64457744 | Drug | JNJ-64457744 will be administered as oral solution. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1, 2 and 3: Number of Participants With Serious Adverse Events (SAEs) | 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; suspected transmission of any infectious agent via medicinal product; or any important medical events. | Up to Week 8 |
| Part 1, 2 and 3: Number of Participants With SAEs by Severity | 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; suspected transmission of any infectious agent via medicinal product; or any important medical events. Severity will be graded according to the Division of Division of Acquired Immunodeficiency Syndrome (DAIDS) grading table where Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Potentially Life-threatening. | Up to Week 8 |
| Part 1, 2 and 3: Number of Participants With Clinical Laboratory Abnormalities | Number of participants with clinical laboratory abnormalities (including hematology, biochemistry, coagulation, urinalysis) will be reported. | Up to 8 weeks |
| Part 1, 2 and 3: Number of Participants With Clinical Laboratory Abnormalities by Severity | Number of participants with clinical laboratory abnormalities (including hematology, biochemistry, coagulation, urinalysis) will be reported. Severity will be graded according to the Division of AIDS (DAIDS) grading table where Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Potentially Life-threatening. | Up to 8 weeks |
| Part 1, 2 and 3: Number of Participants With Electrocardiograms (ECGs), Echocardiography, Vital Signs and Physical Examination Abnormalities |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Plasma Concentration of JNJ-64457744: Within-Participant Analysis | Plasma concentration of JNJ-64457744 assessed within-participant after administration of 3 different single doses under fasted conditions will be reported. | Up to 5 weeks |
| Part 1: Plasma Concentration of JNJ-64457744 Under Fed and Fasted Condition |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research and Development, LLC Clinical Trial | Janssen Research and Development LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Zealand Clinical Research | Grafton | 1010 | New Zealand |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| C442442 | tenofovir alafenamide |
| C413685 | entecavir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
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| Part 1: JNJ-64457744 (Cohort K) | Experimental | Optional Cohort K: Non-Asian healthy participants will receive an oral formulation of JNJ-64457744 in the first intervention period and will cross over to receive the other formulation during the second intervention period, under fasted conditions on Day 1. |
|
| Part 2 JNJ-64457744 or Placebo | Experimental | Chronic hepatitis B participants who are virologically suppressed on nucleos(t)ide analog (NA) treatment (tenofovir disoproxil fumarate [TDF], tenofovir alafenamide [TAF] and entecavir [ETV]) will receive a single dose at one single dose level of either JNJ-64457744 or matching placebo as an oral formulation, under fasted condition on Day 1. |
|
| Part 3: JNJ-64457744 or Placebo (Multiple Ascending Doses [MADs]) | Experimental | Participants will receive MADs of either JNJ-64457744 or matching placebo once weekly under fasted conditions as an oral formulation. |
|
| Placebo | Drug | Placebo will be administered as an oral formulation. |
|
| Tenofovir Disoproxil Fumarate (TDF) | Drug | TDF tablet will be administered orally |
|
| Tenofovir Alafenamide (TAF) | Drug | TAF tablet will be administered orally. |
|
| Entecavir (ETV) | Drug | ETV tablet will be administered orally. |
|
| JNJ-64457744 | Drug | JNJ-64457744 will be administered as oral tablet. |
|
Number of participants with abnormalities in ECGs, echocardiography, vital signs and physical examination will be reported. |
| Up to Week 8 |
| Part 1, 2 and 3: Number of Participants With Electrocardiograms (ECGs), Echocardiography, Vital Signs and Physical Examination Abnormalities by Severity | Number of participants with abnormalities in ECGs, echocardiography, vital signs and physical examination will be reported. Severity will be graded according to the Division of AIDS (DAIDS) grading table where Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Potentially Life-threatening. | Up to 8 weeks |
| Part 1, 2 and 3: Plasma concentration of JNJ-64457744 | Plasma concentration of JNJ-64457744 will be reported. | Up to Week 8 |
Plasma Concentration of JNJ-64457744 under fed and fasted conditions will be reported. |
| Up to 5 weeks |
| Part 1: Plasma Concentration of JNJ-64457744 Under Fasted Condition in Healthy Adult Asian Participants | Plasma concentration of JNJ-64457744 under fasted conditions in healthy adult Asian participants will be reported. | Up to 5 weeks |
| Part 1: Plasma Concentration of JNJ-64457744 Formulation Under Fasted Conditions | Plasma Concentration of JNJ-64457744 formulation as compared with an oral solution formulation under fasted conditions will be reported. | Up to 5 weeks |
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |