A 3-Part, Randomized, Placebo-controlled, Double-blind, Single Ascending Dose Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-69095897 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Part 3: Cerebrospinal Fluid (CSF) Concentration of JNJ-69095897 and its Possible Metabolites
研究概览
简要总结
The purpose of this study is to investigate the safety and tolerability of JNJ-69095897 versus placebo and to characterize the pharmacokinetic (PK) of JNJ-69095897 in blood, plasma, cerebrospinal fluid (CSF) and urine after single or divided oral dose administration 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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Otherwise, healthy based on physical examination, medical history, vital signs, orthostatic blood pressure measurements and 12-lead Electrocardiography (ECG) (means of triplicate ECG, inclusive, QT corrected according to Fridericia's formula [QTcF] less than or equal to [<=] 450 millisecond [msec] for males and <= 470 msec for females) performed at screening and admission to the clinical unit. Minor abnormalities in ECG, blood pressure and heart rate, which are not considered to be of clinical significance by the investigator, are acceptable, with the exception of bradycardia <= 45 beats per minutes (bpm) on 12-lead safety ECG, that will be exclusionary at screening, admission to the clinical unit or prior to the first dose on the dosing day
- •Otherwise, healthy based on clinical laboratory tests performed at screening. If the results of the serum chemistry panel including liver enzymes, hematology, or urinalysis are outside the normal reference ranges, the participant may be included at the discretion of the investigator, provided the investigator judges the abnormalities to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
- •Participant has a body mass index (BMI) between 18.0 and 30.0 kilogram/meter square (kg/m^2) inclusive (BMI=weight/height^2)
- •Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
- •Each participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for the study and is willing to participate in the study. Participation in the pharmacogenomic part of the study is mandatory
排除标准
- •Has a history of or current significant medical illness including (but not limited to) cardiac arrhythmias or other significant cardiac disease, orthostatic hypotension, liver or renal insufficiency, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances or any other illness that the investigator considers should exclude the participant
- •Has a diagnosis or suspicions of any sleep disorder in the last 6 months or current complaints of sleep disturbance, irregular sleep schedule or shift work; habitual daytime naps; travel across time zones in the last 4 weeks or daytime symptoms attributable to unsatisfactory sleep
- •Has a history of or current major or clinically relevant psychiatric disorder as classified according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) (example, mood, anxiety disorders, psychotic disorder et cetera)
- •Has had a clinically significant acute illness within 7 days prior to study intervention administration
- •Has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with written concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence)
研究组 & 干预措施
Part 1: Single Ascending Dose (SAD) Cohorts (Double-blind)
Healthy male participants will receive JNJ-69095897 or matching placebo orally in Cohorts 1-8.
干预措施: JNJ-69095897 (Drug)
Part 1: Single Ascending Dose (SAD) Cohorts (Double-blind)
Healthy male participants will receive JNJ-69095897 or matching placebo orally in Cohorts 1-8.
干预措施: Placebo (Other)
Part 2: Single Dose Cohort (Open-label)
Healthy male participants will receive JNJ-69095897 orally in Cohort 9.
干预措施: JNJ-69095897 (Drug)
Part 3: Single or Divided Dose Cohort (Double-blind)
Healthy male participants and women of non-childbearing potential (WONCBP) will receive JNJ-69095897 or matching placebo orally in Cohort 10.
干预措施: JNJ-69095897 (Drug)
Part 3: Single or Divided Dose Cohort (Double-blind)
Healthy male participants and women of non-childbearing potential (WONCBP) will receive JNJ-69095897 or matching placebo orally in Cohort 10.
干预措施: Placebo (Other)
结局指标
主要结局
Part 3: Cerebrospinal Fluid (CSF) Concentration of JNJ-69095897 and its Possible Metabolites
时间窗: Up to Day 2
CSF concentration of JNJ-69095897 and its possible metabolites will be reported.
Plasma Concentration of JNJ-69095897 and its Possible Metabolites
时间窗: Up to Day 14
Plasma concentration of JNJ-69095897 and its possible metabolites will be reported.
Number of Participants with Adverse Events (AEs)
时间窗: Up to Day 14
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.
Number of Participants with Electrocardiogram (ECG) Abnormalities
时间窗: Up to Day 14
Number of participants with ECG abnormalities will be reported.
Number of Participants with Clinical Laboratory Abnormalities (Chemistry, Hematology, Urinalysis)
时间窗: Up to Day 14
Number of participants with clinical laboratory abnormalities including chemistry, hematology and urinalysis will be reported.
Number of Participants with Vital Sign Abnormalities
时间窗: Up to Day 14
Number of participants with vital sign abnormalities including heart/pulse rate, systolic blood pressure, diastolic blood pressure, tympanic body temperature and respiratory rate will be reported.
Number of Participants with Holter Recording Abnormalities
时间窗: Up to Day 2
Number of participants with Holter recording abnormalities (including heart rate variability \[HRV\]) will be reported.
Part 1: Urine Concentration of JNJ-69095897 and its Possible Metabolites
时间窗: Up to Day 4
Urine concentration of JNJ-69095897 and its possible metabolites will be reported.
次要结局
- Plasma and CSF Concentration of Endogenous Metabolites(Day 1)