An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of JNJ-77242113 Following Oral Administration in Healthy Chinese Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Apparent Volume of Distribution (Vz/F) of JNJ-77242113
研究概览
简要总结
The purpose of the study is to assess what drug does to body when healthy Chinese participants receive single oral dose of JNJ-77242113.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. If there are any abnormalities, they must be consistent with the underlying illness in the study population or considered not clinically relevant and this determination must be recorded in the participant's source documents and initialed by the investigator
- •Body mass index (BMI; weight kilograms [kg] per height [meter^2]) between 18.0 and 27.9 kilograms per meter^2 (kg/m2) (inclusive), and body weight not less than 50.0 kg at screening
- •A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and on Day -1
- •Blood pressure (after the participant is supine for 5 minutes) between 90 (inclusive) and 140 millimeters of mercury (mmHg) (exclusive) systolic, and no higher than 90 mm Hg diastolic
- •Must be a nonsmoker or habitually smokes no more than 5 cigarettes or equivalent of e-cigarettes, or 2 cigars, or 2 pipes of tobacco per day for at least 6 months before study drug administration
排除标准
- •History of surgical resection of the stomach, small or large intestine (excluding appendectomy, cholecystectomy, or resection of benign polyps)
- •History of use of medications such as nonsteroidal anti-inflammatory drugs (NSAIDS) or aspirin within 28 days prior to screening or planned use during the study
- •Clinically significant infection within 30 days prior to screening or any serious infection within 6 months prior to screening requiring intravenous antimicrobial therapy
- •Known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its excipients
- •History of severe allergic or anaphylactic reactions
研究组 & 干预措施
Cohort 1: JNJ-77242113 Dose 1
Participants will receive a single oral dose of JNJ-77242113 Dose 1 on Day 1.
干预措施: JNJ-77242113 (Drug)
Cohort 2: JNJ-77242113 Dose 2
Participants will receive a single oral dose of JNJ-77242113 Dose 2 on Day 1.
干预措施: JNJ-77242113 (Drug)
Cohort 3: JNJ-77242113 Dose 3
Participants will receive a single oral dose of JNJ-77242113 Dose 3 on Day 1.
干预措施: JNJ-77242113 (Drug)
结局指标
主要结局
Apparent Volume of Distribution (Vz/F) of JNJ-77242113
时间窗: Predose up to Day 3
Vz/F is defined as apparent volume based on terminal phase after extravascular administration of distribution of JNJ-77242113.
Maximum Observed Plasma Concentration (Cmax) of JNJ-77242113
时间窗: Predose up to Day 3
Cmax is defined as maximum observed plasma concentration of JNJ-77242113.
Area Under the Plasma Concentration versus Time Curve From Time Zero to Time of the Last Measurable Concentration (AUC[0-last]) of JNJ-77242113
时间窗: Predose up to Day 3
AUC(0-last) is defined as area under the plasma concentration versus time curve from time zero to time of the last measurable concentration of JNJ-77242113.
Area Under the Plasma Concentration versus Time Curve From Time Zero to Infinite Time (AUC[0-infinite]) of JNJ-77242113
时间窗: Predose up to Day 3
AUC(0-infinite) is defined as area under the plasma concentration versus time curve from time zero to infinite time of JNJ-77242113.
Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-77242113
时间窗: Predose up to Day 3
Tmax is defined as time to reach the maximum observed plasma concentration of JNJ-77242113.
Apparent Elimination Half-life (T1/2) of JNJ-77242113
时间窗: Predose up to Day 3
T1/2 is defined as apparent elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of JNJ-77242113.
Apparent Total Systemic Clearance (CL/F) of JNJ-77242113
时间窗: Predose up to Day 3
CL/F is defined as apparent total systemic clearance after extravascular administration of JNJ-77242113.
次要结局
- Number of Participants with Abnormalities in Physical Examinations(Up to Day 35)
- Number of Participants with Abnormalities in Vital Signs(Up to Day 35)
- Number of Participants with Abnormalities in Clinical Laboratory Tests(Up to Day 35)
- Number of Participants with Adverse Events (AEs)(Up to Day 35)
- Number of Participants with Abnormalities in 12-Lead Electrocardiogram (ECG)(Up to Day 35)