A 3-Part, Randomized, Placebo-controlled, Double-blind, Single Dose Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-64140284 in Healthy Male Participants
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Part 1: Plasma Concentration of JNJ-64140284
研究概览
简要总结
The purpose of the study is to investigate and compare the pharmacokinetic (PK) profiles of a single dose of two solid dosage formulations of JNJ-64140284 in plasma and urine in healthy male participants under fed and fasting conditions; and to investigate the safety and tolerability of two solid dosage formulations of JNJ 64140284 versus placebo after single oral dose administration in healthy male participants under fed and fasting conditions in Part 1; to investigate the safety and tolerability of JNJ-64140284 versus placebo after single oral dose administration (or 1 divided dose, if applicable) (ascending dose levels) in healthy male participants; and to characterize the PK of a single dose (or 1 divided dose, if applicable) of JNJ-64140284 in plasma in healthy male participants in Part 2; and to investigate the effect of food on the PK of a single (or 1 divided dose, if applicable) therapeutic relevant dose of JNJ 64140284 in healthy male participants; and to investigate the safety and tolerability of JNJ-64140284 versus placebo after single oral dose administration at a therapeutic relevant dose (or 1 divided dose, if applicable) in fed conditions in Part 3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 54 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Part 1: Cohort 1 (Placebo or JNJ-64140284)
Participants will receive matching placebo in Treatment A or JNJ-64140284 (as formulation 1) in Treatment B or JNJ-64140284 (as formulation 2) in Treatment C on Day 1 under fasted condition. Participants will receive treatment in either of the 6 treatment sequences (ABC, BCA, CAB, CBA, ACB or BAC) in Period 1, 2, or 3 under fasted condition. Each period is separated by washout period of 5 days.
干预措施: JNJ-64140284 (Drug)
Part 1: Cohort 1 (Placebo or JNJ-64140284)
Participants will receive matching placebo in Treatment A or JNJ-64140284 (as formulation 1) in Treatment B or JNJ-64140284 (as formulation 2) in Treatment C on Day 1 under fasted condition. Participants will receive treatment in either of the 6 treatment sequences (ABC, BCA, CAB, CBA, ACB or BAC) in Period 1, 2, or 3 under fasted condition. Each period is separated by washout period of 5 days.
干预措施: Placebo (Drug)
Part 1: Cohort 2 (Placebo or JNJ-64140284)
Participants will receive matching placebo (Treatment D) or JNJ- 64140284 (as formulation 1) in Treatment E or JNJ-64140284 (as formulation 2) in Treatment F. Participants will receive treatment in either of 6 treatment sequence (DEF, EFD, FDE, FED, DFE or EDF) in Period 1, 2, or 3 under fed condition. Each period is separated by washout period of 5 days.
干预措施: JNJ-64140284 (Drug)
Part 1: Cohort 2 (Placebo or JNJ-64140284)
Participants will receive matching placebo (Treatment D) or JNJ- 64140284 (as formulation 1) in Treatment E or JNJ-64140284 (as formulation 2) in Treatment F. Participants will receive treatment in either of 6 treatment sequence (DEF, EFD, FDE, FED, DFE or EDF) in Period 1, 2, or 3 under fed condition. Each period is separated by washout period of 5 days.
干预措施: Placebo (Drug)
Part 2: Cohorts 1-7 (JNJ-64140284 or Placebo)
Participants will receive JNJ 64140284 formulation 1 or 2 or matching placebo under fasting condition in Cohorts 1 to 7 on Day 1.
干预措施: JNJ-64140284 (Drug)
Part 2: Cohorts 1-7 (JNJ-64140284 or Placebo)
Participants will receive JNJ 64140284 formulation 1 or 2 or matching placebo under fasting condition in Cohorts 1 to 7 on Day 1.
干预措施: Placebo (Drug)
Part 3: Cohorts 1-2 (JNJ-64140284 or placebo)
Participants will receive JNJ-64140284 formulation 1 or 2 or matching placebo under fed condition in Cohorts 1 to 2 on Day 1.
干预措施: JNJ-64140284 (Drug)
Part 3: Cohorts 1-2 (JNJ-64140284 or placebo)
Participants will receive JNJ-64140284 formulation 1 or 2 or matching placebo under fed condition in Cohorts 1 to 2 on Day 1.
干预措施: Placebo (Drug)
结局指标
主要结局
Part 1: Plasma Concentration of JNJ-64140284
时间窗: Pre-dose, Day 1, 2, 3 and Day 4
Plasma samples will be analyzed to determine concentrations of JNJ-64140284 under fed and fasting conditions using a validated, specific and sensitive liquid chromatography-mass spectrometry (LC-MS/MS).
Part 3: Ratio of Area Under Plasma Concentration Curve (AUC) and Maximum Plasma Concentration (Cmax)
时间窗: Pre-dose, Day 1, 2, 3 and Day 4
Ratio of geometric means for pharmacokinetics (PK) parameters (AUCs and Cmax) of JNJ 64140284 (fed versus fasted condition) will be analyzed to determine the food effect.
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability: Part 1, Part 2, and Part 3
时间窗: Up to 1.5 years
An adverse event is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An adverse event does not necessarily have a causal relationship with the intervention. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product.
Part 1: Urine Concentration of JNJ-64140284
时间窗: Pre-dose, Day 1, 2, 3 and Day 4
Urine samples will be analyzed to determine concentrations of JNJ-64140284 in renal clearance.
Part 2: Plasma Concentration After Single Dose Administration of JNJ-64140284
时间窗: Pre-dose, Day 1, 2, 3 and Day 4
Plasma samples will be analyzed to determine concentrations of JNJ-64140284 under fed and fasting conditions using a validated, specific and sensitive liquid chromatography-mass spectrometry (LC-MS/MS).
次要结局
- Bond & Lader Visual Analogue Scale (VAS) Score: Part 1 and Part 2(Day -1, 1, 2 and Day 3)
- Karolinska Sleepiness Scale (KSS) Score: Part 1 and Part 2(Day -1, 1, 2 and Day 3)
- Body Sway(Day -1, 1, 2 and Day 3)
- Part 2: Pharmacodynamics (PD) as Assessed by Cognitive Test Battery: Detection Task (DET)(Day -1, 1, 2 and Day 3)
- Part 2: PD as Assessed by Cognitive Test Battery: Identification Task (IDN)(Day -1, 1, 2 and Day 3)
- Part 2: PD as Assessed by Cognitive Test Battery: One Card Learning Task (OCL)(Day -1, 1, 2 and Day 3)
- Part 2: PD as Assessed by Cognitive Test Battery: One Back Task (ONB)(Day -1, 1, 2 and Day 3)
- Part 2: PD as Assessed by Cognitive Test Battery: Groton Maze Learning Test (GMLT)(Day -1, 1, 2 and Day 3)
- Part 2: PD as Assessed by Cognitive Test Battery: International Shopping List Test (ISLT)(Day -1, 1, 2 and Day 3)
- Part 2: PD as Assessed by Cognitive Test Battery: International Shopping List Test delayed (ISLT-D)(Day -1, 1, 2 and Day 3)
- Part 2: PD as Assessed by Cognitive Test Battery: Groton Maze Learning Test delayed (GMLT-D)(Day -1, 1, 2 and Day 3)