A Study to Compare Two Different Subcutaneously-administered JNJ-64304500 Formulations in Healthy Participants

NCT ID: NCT04667052

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-13
• Study Completion Date: 2021-06-15

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

JNJ 64304500: Reference

Participants (including individuals of Han Chinese background) will be randomized to receive a single subcutaneous dose of JNJ-64304500 reference formulation.

Group Type: EXPERIMENTAL

JNJ 64304500

Intervention Type: DRUG

Participants will receive a single subcutaneous dose of JNJ-64304500 reference formulation.

JNJ 64304500: Test

Participants (including individuals of Han Chinese background) will be randomized to receive a single subcutaneous dose of JNJ-64304500 test formulation.

Group Type: EXPERIMENTAL

JNJ 64304500

Intervention Type: DRUG

Participants will receive a single subcutaneous dose of JNJ-64304500 test formulation.

Interventions

JNJ 64304500

Participants will receive a single subcutaneous dose of JNJ-64304500 reference formulation.

Intervention Type: DRUG

JNJ 64304500

Participants will receive a single subcutaneous dose of JNJ-64304500 test formulation.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

WCCT Global, LLC

Cypress, California, United States

Countries

United States

Other Identifiers

64304500CRD1002

Identifier Type: OTHER

Identifier Source: secondary_id

2020-003559-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR108796

Identifier Type: -

Identifier Source: org_study_id