Status:
TERMINATED
A Single and Multiple Ascending Dose Study of JNJ-64457744
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Healthy
Hepatitis B, Chronic
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 part...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
July 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05423106
Start Date
July 4 2022
End Date
March 20 2023
Last Update
February 3 2025
Active Locations (1)
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1
New Zealand Clinical Research
Grafton, New Zealand, 1010