A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of JNJ-70075200 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
The purpose of the study is to evaluate safety and tolerability of JNJ-70075200 compared with placebo after administration of single ascending doses of JNJ-70075200 as oral solution (Part 1); multiple ascending doses of JNJ-70075200, administered as oral solution over 14 consecutive days (Part 2); and the option of a single dose of JNJ-70075200 administered as an oral solid formulation (Part 3).
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 55 Years（Adult）
- 性别
- All
- 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: Single Ascending Dose (SAD)
Participants will receive an oral solution of JNJ-70075200 or placebo in single ascending doses on Day 1 in cohorts 1, 2, 3, 4, 5a and 6 under fasted condition. Participants in cohort 5a will additionally receive the same study intervention under fed condition (Cohort 5b) after a washout period of at least 7 days.
干预措施: JNJ-70075200 (Drug)
Part 1: Single Ascending Dose (SAD)
Participants will receive an oral solution of JNJ-70075200 or placebo in single ascending doses on Day 1 in cohorts 1, 2, 3, 4, 5a and 6 under fasted condition. Participants in cohort 5a will additionally receive the same study intervention under fed condition (Cohort 5b) after a washout period of at least 7 days.
干预措施: Placebo (Drug)
Part 2: Multiple Ascending Dose (MAD)
After assessment of safety, tolerability and pharmacokinetics data in Part 1, participants will receive an oral solution of JNJ-70075200 or placebo twice daily in Cohorts 1 to 6 for 14 days under fasted/fed condition.
干预措施: JNJ-70075200 (Drug)
Part 2: Multiple Ascending Dose (MAD)
After assessment of safety, tolerability and pharmacokinetics data in Part 1, participants will receive an oral solution of JNJ-70075200 or placebo twice daily in Cohorts 1 to 6 for 14 days under fasted/fed condition.
干预措施: Placebo (Drug)
Part 3: Single-dose Oral Solid Formulation (Optional)
Participants will receive oral dose of JNJ-70075200 on Day 1 in Cohort 1 under fasted condition. Part 3 will start after obtaining a formal regulatory/ethical approval.
干预措施: JNJ-70075200 (Drug)
结局指标
主要结局
Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)
时间窗: Up to 1 year and 1 month
An adverse event (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. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
Number of Participants with Clinically Significant Changes in Physical Examination
时间窗: Up to 1 year and 1 month
Number of participants with clinically significant changes in physical examination will be assessed.
Change from Baseline in Heart Rate (HR)
时间窗: Baseline, up to 1 year and 1 month
Change from baseline in HR will be measured by ECG.
Change from Baseline in PR Interval
时间窗: Baseline, up to 1 year and 1 month
Change from baseline in PR interval will be measured by ECG.
Percentage of Participants with Serious Adverse Events (SAEs)
时间窗: Up to 1 year and 1 month
A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
Number of Participants with Clinically Significant Changes in Vital Signs
时间窗: Up to 1 year and 1 month
Number of participants with clinically significant changes in vital signs will be assessed.
Change From Baseline in QTc Interval
时间窗: Baseline, up to 1 year and 1 month
Change from baseline in QT interval corrected for heart rate (QTc interval) using Fridericia method will be measured by electrocardiogram (ECG).
Number of Participants With Clinically Significant Laboratory Abnormalities
时间窗: Up to 1 year and 1 month
Number of participants with clinically significant laboratory abnormalities related to hematology and clinical chemistry will be reported.
Change from Baseline in QRS Interval
时间窗: Baseline, up to 1 year and 1 month
Change from baseline in QRS interval will be measured by ECG.
Change From Baseline in QT Interval
时间窗: Baseline, up to 1 year and 1 month
Change from baseline in QT interval will be measured by ECG.
次要结局
- Part 1 and 3: Percentage of Participants with SAEs (Food Effect)(Up to 1 year and 1 month)
- Part 1 and 3: Number of Participants with Clinically Significant Changes in Vital Signs (Food Effect)(Up to 1 year and 1 month)
- Part 1 and 3: Number of Participants with Clinically Significant Changes in Physical Examination (Food Effect)(Up to 1 year and 1 month)
- Part 1 and 3: Number of Participants With Clinically Significant Laboratory Abnormalities (Food Effect)(Up to 1 year and 1 month)
- Part 1 and 3: Change From Baseline in QTc Interval (Food Effect)(Baseline, up to 1 year and 1 month)
- Part 1, 2 and 3: Plasma Concentration of JNJ-70075200 Over Time(Part 1 and Part 3: Predose, up to 72 hours postdose (up to Day 4), Part 2: Predose, up to 24 hours postdose (up to Day 15))
- Part 1 and Part 3: Change from Baseline in QRS Interval (Food Effect)(Baseline, up to 1 year and 1 month)
- Part 1 and Part 3: Change from Baseline in HR (Food Effect)(Baseline, up to 1 year and 1 month)
- Part 1 and 3: Plasma Concentration of JNJ-70075200 Over Time (Food Effect)(Predose, up to 72 hours postdose (up to Day 4))
- Part 1 and 3: Percentage of Participants with TEAEs (Food Effect)(Up to 1 year and 1 month)
- Part 1 and Part 3: Change from Baseline in PR Interval (Food Effect)(Baseline, up to 1 year and 1 month)
- Part 1 and Part 3: Change From Baseline in QT Interval (Food Effect)(Baseline, up to 1 year and 1 month)