A Double-blind, Placebo-controlled, Randomized, Single Ascending Dose and Multiple Dose Study to Investigate Safety, Tolerability, and Pharmacokinetics of JNJ-40411813 in Healthy Japanese Adult Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Parts 1 and 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) after single dose and multiple dose administrations of JNJ-40411813 in Japanese healthy adult male 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
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Be a Japanese man
- •Be healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
- •Blood pressure (after the participant supine for 5 minutes) between 90 and 140 millimeter of Mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic. If blood pressure is out of range, up to 2 repeated assessments are permitted
- •During the study and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of study intervention, a participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person. Male participants should also be advised of the benefit for a female partner to use a highly effective method of contraception as condom may break or leak. Recommended highly effective methods of contraception in this study for female partners of male participants to use in addition to the male participant wearing a condom during include: a) oral hormonal contraception, b) intrauterine device, c) intrauterine hormone-releasing system, and d) bilateral tubal occlusion
- •A participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum 90 days after receiving the last dose of study intervention
排除标准
- •History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- •Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening as deemed appropriate by the investigator
- •Clinically significant abnormal physical examination, vital signs, or 12 lead electrocardiogram (ECG) at screening as deemed appropriate by the investigator
- •Known allergies, hypersensitivity, or intolerance to JNJ-40411813 or its excipients
- •Test positive for human immunodeficiency virus (HIV) antigen/antibodies, hepatitis A antibody immunoglobulin M (IgM), syphilis, hepatitis B surface antigen (HbsAg) or hepatitis C virus (HCV) antibodies at screening
研究组 & 干预措施
Part 1: JNJ-40411813 or Matching Placebo
Participants will receive a single oral dose of JNJ-40411813 or a matching placebo in Cohorts 1, 2, and 3.
干预措施: JNJ-40411813 (Drug)
Part 1: JNJ-40411813 or Matching Placebo
Participants will receive a single oral dose of JNJ-40411813 or a matching placebo in Cohorts 1, 2, and 3.
干预措施: Matching Placebo (Drug)
Part 2: JNJ-40411813
Participants will receive a single oral dose of JNJ-40411813 in Cohort 4.
干预措施: JNJ-40411813 (Drug)
Part 3: JNJ-40411813 or Matching Placebo
Participants will receive a multiple oral dose of JNJ-40411813 or a matching placebo in Cohort 5 and optional Cohort 6.
干预措施: JNJ-40411813 (Drug)
Part 3: JNJ-40411813 or Matching Placebo
Participants will receive a multiple oral dose of JNJ-40411813 or a matching placebo in Cohort 5 and optional Cohort 6.
干预措施: Matching Placebo (Drug)
结局指标
主要结局
Parts 1 and 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
时间窗: Up to 6 weeks
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/biological agent under study.
Part 3: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
时间窗: Up to 8 weeks
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/biological agent under study.
Parts 1 and 2: Plasma Concentration of JNJ-40411813
时间窗: Predose, up to 96 hours postdose (Day 5)
Plasma samples will be analyzed to determine concentrations of JNJ-40411813 using a validated, specific, and sensitive liquid chromatography mass spectrometry/mass spectrometry (LC-MS/MS).
Part 3: Plasma Concentration of JNJ-40411813
时间窗: Predose, up to 312 hours postdose (Day 14)
Plasma samples will be analyzed to determine concentrations of JNJ-40411813 using a validated, specific, and sensitive LC-MS/MS.
次要结局
未报告次要终点