A Study of JNJ-61393215 in Healthy Japanese Male Participants

NCT ID: NCT04713930

Last Updated: 2025-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-29
• Study Completion Date: 2021-05-31

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) after single dose administrations of JNJ-61393215 in Japanese healthy adult male participants.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

JNJ-61393215

Participants will receive one of 3 single oral doses of JNJ-61393215 on Day 1, escalated sequentially based on the safety review in Cohorts 1, 2, and 3 up to Day 5.

Group Type: EXPERIMENTAL

JNJ-61393215

Intervention Type: DRUG

JNJ-61393215 will be administered orally.

Placebo

Participants will receive a single oral dose of placebo on Day 1 in Cohorts 1, 2, and 3 up to Day 5.

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo will be administered orally.

Interventions

JNJ-61393215

JNJ-61393215 will be administered orally.

Intervention Type: DRUG

Placebo

Placebo will be administered orally.

Intervention Type: DRUG

Other Intervention Names

Orexin-1

Eligibility Criteria

Inclusion Criteria

• Body mass index (BMI = weight/height^2) between 18 and 30 kilogram per meter square (kg/m^2) (inclusive), and body weight not less than 50 kilogram (kg)
• Be healthy on the basis of physical examination, medical history, vital signs, and 12 lead electrocardiogram (ECG) (including QT interval corrected according to Fridericia's formula [QTcF] less than or equal to [<=] 450 millisecond [msec]) performed at screening. Minor abnormalities in ECG, which are not considered to be of clinical significance by the investigator, are acceptable
• Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
• Blood pressure (after the participant supine for at least 5 minutes) 90 millimeter of Mercury (mmHg) or more and less than 140 mmHg systolic, and less than 90 mmHg diastolic. If blood pressure is out of range, up to 2 repeated assessments are permitted
• During the study and for a minimum of one spermatogenesis cycle (defined as approximately 90 days) after receiving (the last dose of) study intervention, in addition to the highly effective method of contraception, a man a) who is sexually active with a woman of childbearing potential must agree to use a barrier method of contraception (example, condom with spermicidal foam/gel/film/cream/suppository), b) who is sexually active with a woman who is pregnant must use a condom, c) must agree not to donate sperm. In addition, recommended highly effective methods of contraception in this study for female partners of male participants to use in addition to the male participant wearing a condom include: a) oral hormonal contraception, b) intrauterine device, c) intrauterine hormone-releasing system, and d) bilateral tubal occlusion

Exclusion Criteria

• History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
• Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening as deemed appropriate by the investigator
• Clinically significant abnormal physical examination, vital signs, or 12 lead ECG at screening as deemed appropriate by the investigator
• Known allergies, hypersensitivity, or intolerance to JNJ-61393215 or its excipients
• Test positive for human immunodeficiency virus (HIV) antigen/antibodies, hepatitis A antibody immunoglobulin M (IgM), syphilis, hepatitis B surface antigen (HbsAg) or hepatitis C virus (HCV) antibodies at screening

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Pharmaceutical K.K.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Pharmaceutical K.K., Japan Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutical K.K.

Locations

Souseikai Hakata Clinic

Fukuoka, , Japan

Countries

Japan

Other Identifiers

61393215EDI1005

Identifier Type: OTHER

Identifier Source: secondary_id

CR108937

Identifier Type: -

Identifier Source: org_study_id