A Study of JNJ-64530440 in Healthy Japanese Male Participants

NCT ID: NCT03915886

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-15
• Study Completion Date: 2019-07-17

Brief Summary

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of JNJ-64530440 (JNJ-0440) in healthy Japanese adult male participants after single oral dose administration with ascending dose design.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

JNJ-0440 (Low Dose) or Placebo

Participants will receive single oral dose (low) of JNJ-0440 or matching placebo under fed conditions. The dose will be escalated based on the preliminary safety data from the preceding cohort as per sponsor and investigator discretion.

Group Type: EXPERIMENTAL

JNJ-0440

Intervention Type: DRUG

JNJ-0440 tablets will be administered orally.

Placebo

Intervention Type: DRUG

Matching placebo tablets will be administered orally.

JNJ-0440 (Medium Dose) or Placebo

Participants will receive single oral dose (medium) of JNJ-0440 or matching placebo under fed conditions. The dose will be escalated based on the preliminary safety data from the preceding cohort as per sponsor and investigator discretion.

Group Type: EXPERIMENTAL

JNJ-0440

Intervention Type: DRUG

JNJ-0440 tablets will be administered orally.

Placebo

Intervention Type: DRUG

Matching placebo tablets will be administered orally.

JNJ-0440 (High Dose) or Placebo

Participants will receive single oral dose (high) of JNJ-0440 or matching placebo under fed conditions.

Group Type: EXPERIMENTAL

JNJ-0440

Intervention Type: DRUG

JNJ-0440 tablets will be administered orally.

Placebo

Intervention Type: DRUG

Matching placebo tablets will be administered orally.

Interventions

JNJ-0440

JNJ-0440 tablets will be administered orally.

Intervention Type: DRUG

Placebo

Matching placebo tablets will be administered orally.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Body mass index (BMI; weight [kg]/height^2 [m]^2) between 18.0 and 30.0 kilogram per meter square (kg/m^2) (inclusive), and body weight not less than 50 kilogram (kg), at time of screening
• Healthy on the basis of physical examination, medical history, vital signs, and 12 lead electrocardiogram (ECG) performed at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities 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
• Healthy on the basis of clinical laboratory tests performed at screening and at admission to the study site. If the results of the biochemistry panel including liver enzymes, other specific tests, blood coagulation, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if these are grade 1 abnormal values and 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 participants has been supine for 5 minutes) between 90 and 140 millimeter of Mercury (mm Hg) systolic, inclusive, and no higher than 90 mm Hg diastolic. If blood pressure is out of range, up to 2 repeated assessments are permitted
• Must agree not to donate sperm for the purpose of reproduction during the study and for a minimum 90 days after receiving the study drug

Exclusion Criteria

• Any history of confirmed clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, and urticaria
• Clinically significant abnormal physical examination, vital signs, or 12 lead ECG at screening or at admission to the study site as deemed appropriate by the investigator
• History of confirmed clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy witnessed in previous studies with experimental drugs
• Known allergy to heparin or history of heparin induced thrombocytopenia
• History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 5 years before screening or positive test result(s) for alcohol and/or drugs of abuse (such as hallucinogens, barbiturates, opiates, opioids, cocaine, cannabinoids, amphetamines, and benzodiazepines) at screening or at admission to the study site

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

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: collaborator

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

Sumida Hospital

Tokyo, , Japan

Countries

Japan

Other Identifiers

64530440HEP1001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108603

Identifier Type: -

Identifier Source: org_study_id