A Study of JNJ-64530440 in Healthy Japanese Male Participants
Status and phase
Terminated
Phase 1
Conditions
Healthy
Treatments
Drug: JNJ-0440
Drug: Placebo
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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.
Enrollment
16 patients
Sex
Male
Ages
20 to 55 years old
Volunteers
Accepts Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Sequential Assignment
Masking
Triple Blind
16 participants in 3 patient groups
JNJ-0440 (Low Dose) or Placebo
Experimental group
Description:
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.
Treatment:
Drug: Placebo
Drug: JNJ-0440
JNJ-0440 (Medium Dose) or Placebo
Experimental group
Description:
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.
Treatment:
Drug: Placebo
Drug: JNJ-0440
JNJ-0440 (High Dose) or Placebo
Experimental group
Description:
Participants will receive single oral dose (high) of JNJ-0440 or matching placebo under fed conditions.
Treatment:
Drug: Placebo
Drug: JNJ-0440
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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