A Phase 1, Randomized, Open-label, 4-Period Crossover Study in Healthy Subjects to Assess the Food Effect on a Single Dose of JNJ-64417184 Administered as an Oral Solution
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-64417184
研究概览
简要总结
The purpose of this study is to assess the food effect on the single-dose pharmacokinetic (PK) of the JNJ-64417184 oral solution, administered as 2 different formulations, in healthy adult participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- •Must have a body mass index (BMI; weight [kg]/height^2 [m^2]) between 18.0 and 30.0 kilogram per meter square (kg/m^2), extremes included, and a body weight not less than 50.0 kg at screening
- •Healthy on the basis of physical examination, medical and surgical history, and vital signs performed at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities to be not clinically significant or to be appropriate and reasonable for the population under study
- •Healthy on the basis of clinical laboratory tests performed at screening
- •Must have a normal 12-lead electrocardiogram (ECG) (triplicate) at screening
- •Female participant must have a negative highly sensitive serum beta-human chorionic gonadotropin (beta- hCG) pregnancy test at screening and a negative urine pregnancy test on Day -1
排除标准
- •History of liver or renal dysfunction significant cardiac, vascular, pulmonary, gastrointestinal (such as significant diarrhea, gastric stasis, or constipation that in the investigator's opinion could influence drug absorption or bioavailability), endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances
- •Past history of cardiac arrhythmias (example, extrasystoli, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (example, hypokalemia, family history of long QT Syndrome)
- •Any evidence of heart block or bundle branch block at screening
- •Current human immunodeficiency virus type-1 (HIV-1) or HIV-2 infection (confirmed by antibodies) at screening
- •A history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy witnessed in previous studies with experimental drugs
研究组 & 干预措施
Panel 1: Treatment Sequence ABDC
Participants will receive Treatment A (a single dose of JNJ-64417184 [oral solution with preservatives] in fasted condition) in treatment Period 1; followed by Treatment B (a single dose of JNJ-64417184 [oral solution with preservatives] in fed [high-fat meal] condition) in treatment Period 2; followed by Treatment D (a single dose of JNJ-64417184 [oral solution without preservatives] in fed [high-fat meal] condition) in treatment Period 3, followed by Treatment C (a single dose of JNJ-64417184 [oral solution without preservatives] in fasted condition) in treatment Period 4 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes.
干预措施: JNJ-64417184 (Drug)
Panel 1: Treatment Sequence BCAD
Participants will receive Treatment B in treatment Period 1; followed by Treatment C in treatment Period 2; followed by Treatment A in treatment Period 3, followed by Treatment D in treatment Period 4 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes.
干预措施: JNJ-64417184 (Drug)
Panel 1: Treatment Sequence CDBA
Participants will receive Treatment C in treatment Period 1; followed by Treatment D in treatment Period 2; followed by Treatment B in treatment Period 3, followed by Treatment A in treatment Period 4 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes.
干预措施: JNJ-64417184 (Drug)
Panel 1: Treatment Sequence DACB
Participants will receive Treatment D in treatment Period 1; followed by Treatment A in treatment Period 2; followed by Treatment C in treatment Period 3, followed by Treatment B in treatment Period 4 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes.
干预措施: JNJ-64417184 (Drug)
Optional Panel 2: Treatment Sequence EFG
Participants will receive Treatment E (a single dose of JNJ-64417184 [oral solution with or without preservatives] in fasted condition) in treatment Period 1; followed by Treatment F (a single dose of JNJ-64417184 [oral solution with or without preservatives] in fed [high-fat meal] condition) in treatment Period 2; followed by Treatment G (a single dose of JNJ-64417184 [oral solution with or without preservatives] in fed [high-fat meal] condition) in treatment Period 3 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes.
干预措施: JNJ-64417184 (Drug)
Optional Panel 2: Treatment Sequence FGE
Participants will receive Treatment F in treatment Period 1; followed by Treatment G in treatment Period 2; followed by Treatment E in treatment Period 3 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes.
干预措施: JNJ-64417184 (Drug)
Optional Panel 2: Treatment Sequence GEF
Participants will receive Treatment G in treatment Period 1; followed by Treatment E in treatment Period 2; followed by Treatment F in treatment Period 3 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes.
干预措施: JNJ-64417184 (Drug)
Optional Panel 2: Treatment Sequence GFE
Participants will receive Treatment G in treatment Period 1; followed by Treatment F in treatment Period 2; followed by Treatment E in treatment Period 3 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes.
干预措施: JNJ-64417184 (Drug)
Optional Panel 2: Treatment Sequence EGF
Participants will receive Treatment E in treatment Period 1; followed by Treatment G in treatment Period 2; followed by Treatment F in treatment Period 3 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes.
干预措施: JNJ-64417184 (Drug)
Optional Panel 2: Treatment Sequence FEG
Participants will receive Treatment F in treatment Period 1; followed by Treatment E in treatment Period 2; followed by Treatment G in treatment Period 3 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes.
干预措施: JNJ-64417184 (Drug)
结局指标
主要结局
Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-64417184
时间窗: Up to Day 6
Cmax is the maximum observed plasma analyte concentration.
Area Under the Concentration-time Curve from Time Zero to the Last Measurable Concentration (AUC [0-last]) of JNJ-64417184
时间窗: Up to Day 6
AUC (0-last) is area under the plasma analyte concentration-time curve (AUC) from time 0 to time of the last quantifiable (non-below quantification limit \[non-BQL\]) concentration, calculated by linear-linear trapezoidal summation.
Area Under the Concentration-time Curve from Time Zero to Infinity (AUC [0-infinity]) of JNJ-64417184
时间窗: Up to Day 6
AUC (0-infinity) is the area under the plasma analyte concentration-time curve (AUC) from time zero to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z); wherein AUC (0-last) is area under the plasma concentration-time curve from time zero to last measurable concentration, C(last) is the last observed measurable (non-BQL) analyte concentration; and lambda(z) is apparent terminal elimination rate constant.
次要结局
- Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability(Up to 28 days)
- Acceptability of the JNJ-64417184 Formulation as Assessed by Participant(Up to 28 days)