A Double-blind, Placebo-controlled, Randomized, Single Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-64530440 in Healthy Japanese Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Area Under the Plasma Concentration-time Curve from Time Zero to Last Quantifiable Concentration Time (AUC [0- Last]) of JNJ-0440
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: JNJ-0440 (Drug)
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.
干预措施: Placebo (Drug)
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.
干预措施: JNJ-0440 (Drug)
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.
干预措施: Placebo (Drug)
JNJ-0440 (High Dose) or Placebo
Participants will receive single oral dose (high) of JNJ-0440 or matching placebo under fed conditions.
干预措施: JNJ-0440 (Drug)
JNJ-0440 (High Dose) or Placebo
Participants will receive single oral dose (high) of JNJ-0440 or matching placebo under fed conditions.
干预措施: Placebo (Drug)
结局指标
主要结局
Area Under the Plasma Concentration-time Curve from Time Zero to Last Quantifiable Concentration Time (AUC [0- Last]) of JNJ-0440
时间窗: Up to follow-up visit (approximately up to Day 9)
AUC(0-Last) is area under the plasma concentration-time curve from time zero to time of the last measurable (non-below quantification limit) concentration, calculated by linear-linear trapezoidal summation.
Area Under the Plasma Concentration-time Curve from Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-0440
时间窗: Up to follow-up visit (approximately up to Day 9)
AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC (last) and C(last)/lambda(z); where C(last) is the last observed measurable (non-below quantification limit) concentration.
Apparent Terminal Elimination Rate Constant (Lambda[z]) of JNJ-0440
时间窗: Up to follow-up visit (approximately up to Day 9)
Lambda(z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
Percentage of JNJ-0440 Excreted in Urine (Ae%dose[0-x])
时间窗: Up to 72 hours postdose
The Ae%dose(0-x) is the percentage of cumulative JNJ-0440 dose recovered into the urine for all collection intervals up to x hours postdose, calculated as (Ae/dose\[0-x\])∗100.
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
时间窗: Approximately up to 37 days
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical agent under study.
Apparent Total Clearance (CL/F)
时间窗: Up to follow-up visit (approximately up to Day 9)
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent total clearance of drug after extravascular administration, uncorrected for absolute bioavailability, calculated as dose/AUC(0-infinity).
Percentage of JNJ-0440 Excreted in Urine (Ae%dose[total])
时间窗: Up to 72 hours postdose
Ae%dose(total) is the percentage of total JNJ-0440 dose recovered into the urine for all collection intervals, calculated as (Ae/dose\[total\])∗100.
Apparent Terminal Elimination Half-Life (t1/2) of JNJ-0440
时间窗: Up to follow-up visit (approximately up to Day 9)
The t1/2 is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic analyte concentration time curve, and is calculated as 0.693/lambda(z).
Amount of JNJ-0440 Excreted in Urine within the Time Interval x to y (Ae[x-y])
时间窗: Up to 72 hours postdose
Ae(x-y) is the amount of JNJ-0440 excreted into urine for the collection interval from x to y hours, where x and y are the start and end times of the interval, respectively, calculated by multiplying the urinary volume with the urinary concentration for that interval.
Actual Sampling Time to Reach the Maximum Observed Plasma Analyte Concentration (Tmax) of JNJ-0440
时间窗: Up to follow-up visit (approximately up to Day 9)
Tmax is defined as actual sampling time to reach maximum observed plasma analyte concentration.
Apparent Volume of Distribution (Vdz/F)
时间窗: Up to follow-up visit (approximately up to Day 9)
The Vdz/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution based on the terminal phase after extravascular administration, uncorrected for absolute bioavailability and calculated as dose/(lambda (z)\*AUC\[0-infinity\]).
Total Cumulative Urinary Recovery (Ae[total])
时间窗: Up to 72 hours postdose
Ae(total) is the sum of Ae values for all collection intervals.
Renal Clearance (CLr) of JNJ-0440
时间窗: Up to 72 hours postdose
The CLr is the renal clearance of the drug, calculated as Ae(total)/AUC(0-infinity).
Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-0440
时间窗: Up to follow-up visit (approximately up to Day 9)
Cmax is defined as the maximum observed plasma analyte concentration.
Area Under the Plasma Concentration-time Curve from Time Zero to 24 Hours Postdose (AUC [0- 24h]) of JNJ-0440
时间窗: Up to follow-up visit (approximately up to Day 9)
AUC(0-24h) is area under the plasma concentration-time curve from time zero to 24 hours, calculated by linear-linear trapezoidal summation.
Cumulative Urinary Recovery (Ae[0-x])
时间窗: Up to 72 hours postdose
Ae(0-x) is the sum of Ae values for all collection intervals up to 72 hours postdose.
次要结局
未报告次要终点