HealthyPhase 1NCT05423106
A Single and Multiple Ascending Dose Study of JNJ-64457744
A Phase 1 study testing JNJ-64457744, Tenofovir Disoproxil Fumarate (TDF) and Tenofovir Alafenamide (TAF) in people with Healthy and Hepatitis B, Chronic, run by Janssen Research & Development, LLC at 1 site in New Zealand.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Hepatitis B, Chronic
- What is being tested?
- JNJ-64457744, Tenofovir Disoproxil Fumarate (TDF) and Tenofovir Alafenamide (TAF)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteNew Zealand
- Study dates
- 4 Jul 2022to 20 Mar 2023
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal left ventricular heart function as defined as left ventricular ejection fraction (LVEF) greater than or equal to (>=) 5 percent (%), as assessed by 2 dimension electrocardiogram (2DECHO) at screening
- All women must have a negative urine pregnancy test at screening and Day -1 (of each intervention period, if applicable)
- A woman must not be of childbearing potential
- Part 1 and 3: Must have an estimated creatinine clearance greater than (>) 80 milliliter (mL) per minute at screening, calculated by the modification of diet in renal disease (MDRD) formula
- Part 2: Must have chronic HBV infection. HBV infection must be documented by serum HBsAg positivity at screening
- Must be fully vaccinated against coronavirus disease 2019 (COVID-19) at least 2 weeks prior to screening calculated by the modification of diet in renal disease (MDRD) formula
- Participants in Cohorts A-I and K in Part 1 must not have maternal and paternal parents and/or grandparents of Asian ethnicity (that is, China, Japan, Korea as confirmed by interview) Participants in Cohort J must have maternal and paternal parents and grandparents of Asian ethnicity (that is, China, Japan, Korea as confirmed by interview)
Who cannot join
- History of cardiac arrhythmias (example, extrasystole, tachycardia at rest), history of risk factors for Torsades de Pointes syndrome (example, hypokalemia, family history of long QT syndrome) or history or other clinical evidence of significant or unstable cardiac disease (example, angina, congestive heart failure, myocardial infarction, diastolic dysfunction, significant arrhythmia, coronary heart disease, and/or clinically significant electrocardiogram ([ECG] abnormalities), moderate to severe valvular disease or uncontrolled hypertension at screening. Any evidence of second and third degree heart block or right bundle branch block is also exclusionary
- Participants with abnormal sinus rhythm (heart rate less than [<] 45 or > 100 beats per minute [bpm]), QT corrected for heart rate according to Fridericia's formula (QTcF) > 450 milliseconds (ms) for male participants and > 470 ms for female participants, QRS >= 120 ms, PR interval >220 ms, abnormal conduction, or any other clinically significant abnormalities on a 12-lead ECG at screening
- Family history of inherited mitochondrial disorders such as inherited mitochondrial myopathy, mitochondrial encephalomyopathy with lactic acidosis and stroke-like episodes (MELAS) syndrome
- Known allergies, hypersensitivity, or intolerance to JNJ-64457744 or its excipients
- History of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy witnessed in previous studies with experimental drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Blinded, Randomized, Placebo-controlled, First-in-human Study of Orally Administered JNJ-64457744 to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After Single and Multiple Ascending Doses
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).
- Conditions
- Healthy, Hepatitis B, Chronic
- Being tested
- JNJ-64457744, Placebo, Tenofovir Disoproxil Fumarate (TDF), Tenofovir Alafenamide (TAF), Entecavir (ETV)
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-64457744Drug
JNJ-64457744 will be administered as oral solution.
PlaceboDrug
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-64457744Drug
JNJ-64457744 will be administered as oral tablet.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: JNJ-64457744; Drug: Placebo |
| 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. Receives: Drug: JNJ-64457744 |
| 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. Receives: Drug: JNJ-64457744; Drug: Placebo |
| 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. Receives: Drug: JNJ-64457744; Drug: Placebo |
| 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. Receives: Drug: JNJ-64457744 |
| 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. Receives: Drug: JNJ-64457744; Drug: Placebo; Drug: Tenofovir Disoproxil Fumarate (TDF); Drug: Tenofovir Alafenamide (TAF); Drug: Entecavir (ETV) |
| 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. Receives: Drug: JNJ-64457744; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 8 weeks
Part 1, 2 and 3: Number of Participants With Electrocardiograms (ECGs), Echocardiography, Vital Signs and Physical Examination Abnormalities
Number of participants with abnormalities in ECGs, echocardiography, vital signs and physical examination will be reported.
Measured: 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.
Measured: Up to 8 weeks
Part 1, 2 and 3: Plasma concentration of JNJ-64457744
Plasma concentration of JNJ-64457744 will be reported.
Measured: Up to Week 8
Secondary outcomes (4)
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.
Measured: Up to 5 weeks
Part 1: Plasma Concentration of JNJ-64457744 Under Fed and Fasted Condition
Plasma Concentration of JNJ-64457744 under fed and fasted conditions will be reported.
Measured: 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.
Measured: 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.
Measured: Up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start4 Jul 2022
- Primary completion14 Mar 2023
- Study completion20 Mar 2023
Why it stopped: Strategic business decision, not due to safety concerns
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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research and Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423106
- Sponsor's protocol ID
- CR109208
- Other IDs
- 64457744HPB1001
- Status last verified
- Jan 2025
- First submitted
- 6 Jun 2022
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Blinded, Randomized, Placebo-controlled, First-in-human Study of Orally Administered JNJ-64457744 to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After Single and Multiple Ascending Doses
- ClinicalTrials.gov ID
- NCT05423106
- Acronym / sponsor ID
- CR109208
- Conditions
- Healthy, Hepatitis B, Chronic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic business decision, not due to safety concerns
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 4 Jul 2022 (actual)
- Primary completion
- 14 Mar 2023 (actual)
- Study completion
- 20 Mar 2023 (actual)
- First posted
- 21 Jun 2022 (actual)
- 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 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Part 1: JNJ-64457744 or Placebo (Single Ascending Dose [SAD] Cohorts A-F) | Experimental | Drug: JNJ-64457744, Drug: PlaceboNon-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 | Drug: JNJ-64457744Non-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 | Drug: JNJ-64457744, Drug: PlaceboNon-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 | Drug: JNJ-64457744, Drug: PlaceboAsian 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. |
| Part 1: JNJ-64457744 (Cohort K) | Experimental | Drug: JNJ-64457744Optional 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 | Drug: JNJ-64457744, Drug: Placebo, Drug: Tenofovir Disoproxil Fumarate (TDF), Drug: Tenofovir Alafenamide (TAF), Drug: Entecavir (ETV)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 | Drug: JNJ-64457744, Drug: PlaceboParticipants will receive MADs of either JNJ-64457744 or matching placebo once weekly under fasted conditions as an oral formulation. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Normal left ventricular heart function as defined as left ventricular ejection fraction (LVEF) greater than or equal to (>=) 5 percent (%), as assessed by 2 dimension electrocardiogram (2DECHO) at screening
- All women must have a negative urine pregnancy test at screening and Day -1 (of each intervention period, if applicable)
- A woman must not be of childbearing potential
- Part 1 and 3: Must have an estimated creatinine clearance greater than (>) 80 milliliter (mL) per minute at screening, calculated by the modification of diet in renal disease (MDRD) formula
- Part 2: Must have chronic HBV infection. HBV infection must be documented by serum HBsAg positivity at screening
Key exclusion criteria (5 listed)
- History of cardiac arrhythmias (example, extrasystole, tachycardia at rest), history of risk factors for Torsades de Pointes syndrome (example, hypokalemia, family history of long QT syndrome) or history or other clinical evidence of significant or unstable cardiac disease (example, angina, congestive heart failure, myocardial infarction, diastolic dysfunction, significant arrhythmia, coronary heart disease, and/or clinically significant electrocardiogram ([ECG] abnormalities), moderate to severe valvular disease or uncontrolled hypertension at screening. Any evidence of second and third degree heart block or right bundle branch block is also exclusionary
- Participants with abnormal sinus rhythm (heart rate less than [<] 45 or > 100 beats per minute [bpm]), QT corrected for heart rate according to Fridericia's formula (QTcF) > 450 milliseconds (ms) for male participants and > 470 ms for female participants, QRS >= 120 ms, PR interval >220 ms, abnormal conduction, or any other clinically significant abnormalities on a 12-lead ECG at screening
- Family history of inherited mitochondrial disorders such as inherited mitochondrial myopathy, mitochondrial encephalomyopathy with lactic acidosis and stroke-like episodes (MELAS) syndrome
- Known allergies, hypersensitivity, or intolerance to JNJ-64457744 or its excipients
- History of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy witnessed in previous studies with experimental drugs
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-64457744JNJ-64457744 will be administered as oral solution. | Drug | Part 1: JNJ-64457744 (Cohorts G-H), Part 1: JNJ-64457744 or Placebo (Cohort I), Part 1: JNJ-64457744 or Placebo (Cohort J), Part 1: JNJ-64457744 or Placebo (Single Ascending Dose [SAD] Cohorts A-F), Part 2 JNJ-64457744 or Placebo, Part 3: JNJ-64457744 or Placebo (Multiple Ascending Doses [MADs]) |
| PlaceboPlacebo will be administered as an oral formulation. | Drug | Part 1: JNJ-64457744 or Placebo (Cohort I), Part 1: JNJ-64457744 or Placebo (Cohort J), Part 1: JNJ-64457744 or Placebo (Single Ascending Dose [SAD] Cohorts A-F), Part 2 JNJ-64457744 or Placebo, Part 3: JNJ-64457744 or Placebo (Multiple Ascending Doses [MADs]) |
| Tenofovir Disoproxil Fumarate (TDF)TDF tablet will be administered orally | Drug | Part 2 JNJ-64457744 or Placebo |
| Tenofovir Alafenamide (TAF)TAF tablet will be administered orally. | Drug | Part 2 JNJ-64457744 or Placebo |
| Entecavir (ETV)ETV tablet will be administered orally. | Drug | Part 2 JNJ-64457744 or Placebo |
| JNJ-64457744JNJ-64457744 will be administered as oral tablet. | Drug | Part 1: JNJ-64457744 (Cohort K) |
Primary outcome
Part 1, 2 and 3: Number of Participants With Serious Adverse Events (SAEs)
Time frame: Up to Week 8
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.
Part 1, 2 and 3: Number of Participants With SAEs by Severity
Time frame: Up to Week 8
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.
Part 1, 2 and 3: Number of Participants With Clinical Laboratory Abnormalities
Time frame: Up to 8 weeks
Number of participants with clinical laboratory abnormalities (including hematology, biochemistry, coagulation, urinalysis) will be reported.
Part 1, 2 and 3: Number of Participants With Clinical Laboratory Abnormalities by Severity
Time frame: Up to 8 weeks
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.
Part 1, 2 and 3: Number of Participants With Electrocardiograms (ECGs), Echocardiography, Vital Signs and Physical Examination Abnormalities
Time frame: Up to Week 8
Number of participants with abnormalities in ECGs, echocardiography, vital signs and physical examination will be reported.
Part 1, 2 and 3: Number of Participants With Electrocardiograms (ECGs), Echocardiography, Vital Signs and Physical Examination Abnormalities by Severity
Time frame: Up to 8 weeks
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.
Part 1, 2 and 3: Plasma concentration of JNJ-64457744
Time frame: Up to Week 8
Plasma concentration of JNJ-64457744 will be reported.
4 secondary outcomes
Part 1: Plasma Concentration of JNJ-64457744: Within-Participant Analysis
Time frame: Up to 5 weeks
Part 1: Plasma Concentration of JNJ-64457744 Under Fed and Fasted Condition
Time frame: Up to 5 weeks
Part 1: Plasma Concentration of JNJ-64457744 Under Fasted Condition in Healthy Adult Asian Participants
Time frame: Up to 5 weeks
Part 1: Plasma Concentration of JNJ-64457744 Formulation Under Fasted Conditions
Time frame: Up to 5 weeks
Results and safety
The study was stopped early (reason given: Strategic business decision, not due to safety concerns). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Individual participant dataSharing planned: Yes. 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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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 and 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-64457744, Tenofovir Disoproxil Fumarate (TDF) and Tenofovir Alafenamide (TAF) in people with Healthy and Hepatitis B, Chronic, run by Janssen Research & Development, LLC at 1 site in New Zealand.
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 7 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: stopped early, 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 1 site in New Zealand. 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 was stopped early (reason given: Strategic business decision, not due to safety concerns). Results are not available in the source record.
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, 2 and 3: Number of Participants With Serious Adverse Events (SAEs) (time frame: Up to Week 8). The study lists 7 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 3 Feb 2025.