A Double-blind, Randomized, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-88260237 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Cohort 5: Number of Participants with Abnormalities in Electrocardiogram (ECG)
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of a single oral dose of JNJ-88260237 in healthy participants
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Otherwise, healthy on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG) evaluations performed at screening
- •Body mass index (BMI) within the range 18 to 30 kilogram/meter^2 (kg/m^2) (inclusive)
- •A female must be a) not of childbearing potential defined as postmenopausal or permanently sterile
- •A female must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for a period of 30 days after administration of study intervention
- •A male participant must agree not to donate sperm for the purpose of reproduction or plan to father a child during the study and for a minimum of 90 days after receiving study intervention
排除标准
- •History of liver (with the exception of Gilbert's syndrome or asymptomatic gallstones) or renal insufficiency (estimated glomerular filtration rate [eGFR] below 90 mL/minute at screening only); significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- •Any history of malignancy before screening (exceptions are squamous and basal cell carcinomas of the skin)
- •Had major surgery (example, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from surgery, or has any surgery planned during the time the participant is expected to participate in the study or within 4 weeks after study intervention administration
- •History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism, or excretion of the study intervention(s) (appendectomy and herniotomy allowed, cholecystectomy not allowed)
- •Any current active infections, including localized infections, or any recent history (within 4 weeks prior to administration of study intervention) of active infections, or a history of recurrent, severe, or chronic infections, or otherwise increased risk of infection
研究组 & 干预措施
JNJ-88260237
Participants will be randomized into 6 cohorts to receive single oral dose of JNJ-88260237 on Day 1. The doses in each cohort (Cohorts 2 to 4 and 6) will be escalated based on the safety and pharmacokinetics (PK) data of the previous cohort. For Cohort 5, participants will receive a single-dose of JNJ-82260237 in fasted conditions and a single dose of JNJ-82260237 in fed conditions with dosing sequence determined by randomization.
干预措施: JNJ-88260237 (Drug)
Placebo
Participants in Cohorts 1 to 4 and 6 will receive single oral dose of matching placebo on Day 1.
干预措施: Placebo (Drug)
结局指标
主要结局
Cohort 5: Number of Participants with Abnormalities in Electrocardiogram (ECG)
时间窗: Up to Day 21
Number of participants with abnormalities in ECGs (digital 12-lead ECGs/Holter ECGs) will be reported.
Cohort 1 to 4 and Cohort 6: Number of Participants with Abnormalities in Clinical Safety Laboratory Parameters
时间窗: Up to Day 7
Number of participants with Abnormalities in clinical safety laboratory parameters (including hematology, clinical chemistry, and urinalysis) will be reported.
Cohort 1 to 4 and Cohort 6: Number of Participants with Adverse Events (AEs)
时间窗: Up to Day 14
Number of participants with AEs will be reported.
Cohort 5: Number of Participants with Adverse Events (AEs)
时间窗: Up to Day 24
Number of participants with AEs will be reported.
Cohort 1 to 4 and Cohort 6: Number of Participants with Abnormalities in Vital Signs
时间窗: Up to Day 7
Number of participants with abnormalities in vital signs (including body temperature, pulse rate, respiratory rate, and blood pressure) will be reported.
Cohort 5: Number of Participants with Abnormalities in Vital Signs
时间窗: Up to Day 21
Number of participants with abnormalities in vital signs (including body temperature, pulse rate, respiratory rate, and blood pressure) will be reported.
Cohort 1 to 4 and Cohort 6: Number of Participants with Abnormalities in Electrocardiogram (ECG)
时间窗: Up to Day 7
Number of participants with abnormalities in ECGs (digital 12-lead ECGs/Holter ECGs) will be reported.
Cohort 5: Number of Participants with Abnormalities in Clinical Safety Laboratory Parameters
时间窗: Up to Day 21
Number of participants with Abnormalities in clinical safety laboratory parameters (including hematology, clinical chemistry, and urinalysis) will be reported.
Cohort 1 to 4 and Cohort 6: Number of Participants with Abnormalities in Physical Examinations
时间窗: Up to Day 7
Number of participants with abnormalities in physical examinations will be reported.
Cohort 5: Number of Participants with Abnormalities in Physical Examinations
时间窗: Up to Day 21
Number of participants with abnormalities in physical examinations will be reported.
次要结局
- Maximum Observed Whole Blood Concentration (Cmax) of JNJ-88260237(Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21)
- Time to Reach the Maximum Whole Blood Concentration (Tmax) of JNJ-88260237(Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21)
- Area Under the Whole Blood Concentration Versus Time Curve from Time Zero to Time of the Last Measurable Concentration (AUC [0-Last]) of JNJ-88260237(Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21)
- Area Under the Whole Blood Concentration Versus Time Curve from Time Zero to Infinite Time (AUC [0-Infinity]) of JNJ-88260237(Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21)
- Terminal Half-life (T1/2) of JNJ-88260237(Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21)
- Apparent Oral Whole Blood Clearance (CL/F) of JNJ-88260237(Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21)
- Apparent Volume of Distribution (Vz/F) of JNJ-88260237(Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21)