A Phase 1, Open-Label Study in Healthy Adult Participants to Assess the Pharmacokinetics of JNJ-64281802 Administered as Different Multiple Dose Regimens
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Observed Plasma Concentration of JNJ-64281802 Just Prior to the Beginning of a Dosing Interval (Ctrough)
研究概览
简要总结
The purpose of this study is to assess the pharmacokinetics (PK) of JNJ-64281802 in healthy participants when administered in different multiple dose regimens and as different dose strengths.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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 (at screening only), and vital signs performed at screening and Day -
- •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
- •Body weight not less than 50 kilogram (kg) and body mass index (BMI) within the range 18.0 and 30.0 kilogram per meter square (kg/m^2), extremes included, at screening and Day -1
- •All women must have a negative highly sensitive serum (beta human chorionic gonadotropin [beta hCG]) at screening and a negative urine pregnancy test at Day -1
- •Contraceptive use should be consistent with local regulations regarding the use of contraceptive methods for participant participating in clinical studies
- •Must sign an informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study, before starting any screening activities
排除标准
- •Any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, and urticaria
- •Known allergies, hypersensitivity, or intolerance to JNJ-64281802 or its excipients
- •Has been dosed with JNJ-64281802 in past 3 months
- •Current human immunodeficiency virus type 1 (HIV-1) or type 2 (HIV-2) infection (confirmed by antibodies) at screening
- •Current Coronavirus disease 2019 (COVID-19) infection (confirmed by severe acute respiratory syndrome coronavirus 2 [SARS-CoV2] polymerase chain reaction [PCR]) at the time of admission to the study site (Day -1)
研究组 & 干预措施
Arm A: Panel 1 (JNJ-64281802 High Dose Regimen)
Participants will receive Loading Dose (LD) 1 of JNJ-64281802 twice daily on Days 1 and 2 followed by maintenance Dose (MD) 1 of JNJ-64281802 once daily on Days 3, 10, 17 and 24.
干预措施: JNJ-64281802 (Drug)
Arm A: Panel 2 (JNJ-64281802 High Dose Regimen)
Participants will receive LD 1 of JNJ-64281802 twice daily on Days 1 and 2 followed by MD 2 of JNJ-64281802 once daily on Days 3, 6, 10, 13, 17, 20, 24, and 27.
干预措施: JNJ-64281802 (Drug)
Arm B: Panel 3 (JNJ-64281802 Low Dose Regimen)
Participants will receive LD 2 of JNJ-64281802 twice daily on Days 1 and 2 followed by MD 3 of JNJ-64281802 once daily on Days 3, 10, 17 and 24.
干预措施: JNJ-64281802 (Drug)
Arm B: Panel 4 (JNJ-64281802 Low Dose Regimen)
Participants will receive LD 2 of JNJ-64281802 twice daily on Days 1 and 2 followed by MD 4 of JNJ-64281802 once daily on Days 3, 6, 10, 13, 17, 20, 24, and 27.
干预措施: JNJ-64281802 (Drug)
Arm C: Panel 5 (JNJ-64281802 [Optional])
Participants dosing regimen(s) will be determined based on the results of Study Arm A and Study Arm B.
干预措施: JNJ-64281802 (Drug)
Arm C: Panel 6 (JNJ-64281802 [Optional])
Participants dosing regimen(s) will be determined based on the results of Study Arm A and Study Arm B.
干预措施: JNJ-64281802 (Drug)
结局指标
主要结局
Observed Plasma Concentration of JNJ-64281802 Just Prior to the Beginning of a Dosing Interval (Ctrough)
时间窗: Up to Day 62
Ctrough is defined as observed plasma concentration of JNJ-64281802 just prior to the beginning of a dosing interval.
Maximum Observed Plasma Concentration (Cmax) of JNJ-64281802
时间窗: Up to Day 62
Cmax is defined as maximum observed plasma concentration of JNJ-64281802.
Apparent Terminal Elimination Half-life (t1/2) of JNJ-64281802
时间窗: Up to Day 62
t1/2 is defined as apparent terminal elimination half-life of JNJ-64281802.
Area Under the Curve From Time Zero to tau (AUC[0-tau]) of JNJ-64281802
时间窗: Up to Day 62
AUC(0-tau) is defined as area under the curve from time 0 to tau hours post dose of JNJ-64281802.
Total Apparent Oral Clearance (CL/F) of JNJ-64281802
时间窗: Up to Day 62
CL/F is defined as total apparent oral clearance of JNJ-64281802.
Area Under the Curve From Time Zero to Last Measurable Concentration (AUC[0-last]) of JNJ-64281802
时间窗: Up to Day 62
AUC(0-last) is defined as area under the curve from time 0 to the time of the last measurable concentration of JNJ-64281802.
Area Under the Curve From Time Zero to Infinity (AUC[0-inf]) of JNJ-64281802
时间窗: Up to Day 62
AUC(0-inf) is defined as area under the curve of JNJ-64281802 from time 0 to infinity time.
Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-64281802
时间窗: Up to Day 62
Tmax is defined the actual sampling time to reach the maximum observed plasma concentration of JNJ-64281802.
次要结局
- Number of Participants with Abnormalities in Clinical Laboratory Tests(Up to 62 days)
- Number of Participants with Adverse Events (AEs)(Up to 62 days)
- Number of Participants with Abnormalities in 12-lead Electrocardiograms (ECGs)(Up to 62 days)
- Number of Participants with Abnormalities in Physical Examinations(Up to 62 days)
- Number of Participants with Abnormalities in Vital Sign Measurements(Up to 62 days)