Clinical trial NCT03915886: A Study of JNJ-64530440 in Healthy Japanese Male Participants
Official title: A Double-blind, Placebo-controlled, Randomized, Single Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-64530440 in Healthy Japanese Male Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2019-04-16
Enrollment: 16
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
timeFrame: Approximately up to 37 days
measure: Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-0440
timeFrame: Up to follow-up visit (approximately up to Day 9)
measure: Actual Sampling Time to Reach the Maximum Observed Plasma Analyte Concentration (Tmax) of JNJ-0440
timeFrame: Up to follow-up visit (approximately up to Day 9)
measure: Area Under the Plasma Concentration-time Curve from Time Zero to 24 Hours Postdose (AUC [0- 24h]) of JNJ-0440
timeFrame: Up to follow-up visit (approximately up to Day 9)
measure: Area Under the Plasma Concentration-time Curve from Time Zero to Last Quantifiable Concentration Time (AUC [0- Last]) of JNJ-0440
timeFrame: Up to follow-up visit (approximately up to Day 9)
measure: Area Under the Plasma Concentration-time Curve from Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-0440
timeFrame: Up to follow-up visit (approximately up to Day 9)
measure: Apparent Terminal Elimination Rate Constant (Lambda[z]) of JNJ-0440
timeFrame: Up to follow-up visit (approximately up to Day 9)
measure: Apparent Terminal Elimination Half-Life (t1/2) of JNJ-0440
timeFrame: Up to follow-up visit (approximately up to Day 9)
measure: Apparent Volume of Distribution (Vdz/F)
timeFrame: Up to follow-up visit (approximately up to Day 9)
measure: Apparent Total Clearance (CL/F)
timeFrame: Up to follow-up visit (approximately up to Day 9)
measure: Amount of JNJ-0440 Excreted in Urine within the Time Interval x to y (Ae[x-y])
timeFrame: Up to 72 hours postdose
measure: Cumulative Urinary Recovery (Ae[0-x])
timeFrame: Up to 72 hours postdose
measure: Total Cumulative Urinary Recovery (Ae[total])
timeFrame: Up to 72 hours postdose
measure: Percentage of JNJ-0440 Excreted in Urine (Ae%dose[0-x])
timeFrame: Up to 72 hours postdose
measure: Percentage of JNJ-0440 Excreted in Urine (Ae%dose[total])
timeFrame: Up to 72 hours postdose
measure: Renal Clearance (CLr) of JNJ-0440
timeFrame: Up to 72 hours postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Sumida Hospital
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: STUDY_DIRECTOR
References: