Status:
COMPLETED
A Study to Compare Two Different Subcutaneously-administered JNJ-64304500 Formulations in Healthy Participants
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Healthy
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the relative bioavailability of JNJ-64304500 after administration of two different formulations in healthy participants.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Male or non-childbearing potential female (according to their reproductive organs and functions assigned by chromosomal complement)
- For Han Chinese participants, they need to have resided outside of China for no more than 10 years and have parents and maternal and paternal grandparents who are of Han Chinese ethnicity
- Have a body weight in the range of 60 kilograms (kg) to 90 kg and within a body mass index range between 18 and 30 kilogram per square meters (kg/m\^2), inclusive
- Healthy on the basis of physical examination, medical history, vital signs, and 12 lead electrocardiogram (ECG) performed at screening.
- Healthy on the basis of clinical laboratory tests performed at screening.
- Exclusion criteria:
- History of any clinically significant medical illness or medical disorders the investigator considers should exclude the participant, including (but not limited to) liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- Has a QT corrected according to Fridericia's formula (QTcF) interval greater than (\>) 450 milliseconds (msec) for males, and \>470 msec for females, has a complete left or right bundle branch block, or has a history or current evidence of additional risk factors for torsades de pointes (for example, heart failure, hypokalemia, family history of Long QT Syndrome) at screening and at predose (Day -1)
- Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
- Had major illness or surgery, (for example, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from illness or surgery, or has surgery planned during the time the participant is expected to participate in the study or until Day 113 (Participants who had minor surgical procedures conducted under local anesthesia within 4 weeks before screening may participate)
- Plans to undergo non-major elective surgery within 4 weeks prior to study intervention administration through the end of the study
Exclusion
Key Trial Info
Start Date :
January 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2021
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT04667052
Start Date
January 13 2021
End Date
June 15 2021
Last Update
February 3 2025
Active Locations (1)
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1
WCCT Global, LLC
Cypress, California, United States, 90630