A Double-blind, Randomized, Placebo Controlled, 4-week Study to Investigate the Effect of JNJ-67953964 on Gastric Mucosal Integrity in Healthy Male and Female Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Percentage of Participants with Microscopic Signs of Parietal Cell Damage
研究概览
简要总结
The main purpose of the study is to investigate the upper gastro-intestinal (GI)-related safety and tolerability in healthy participants by gastroscopy and gastric biopsies after treatment with 25 milligram (mg) JNJ-67953964 once daily (QD) over 4 weeks.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) between 18 and 30 kilograms per meter square (kg/m^2). Minimum body weight should be 50 kilogram (kg)
- •Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
- •Non-smokers (not smoked for 3 months prior to screening)
- •A woman of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test before the first dose
- •A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person until 90 days after receiving the last dose of study intervention
排除标准
- •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, which is considered cured with minimal risk of recurrence)
- •History of any gastric surgery, documented gastric disease (including peptic ulcer disease, gastritis, achlorhydria, upper gastro-intestinal (GI) bleeding, esophagitis, or any GI precancerous condition), current clinically evident GI complaints including functional gastrointestinal disorders (FGID)
- •Is positive for helicobacter (H.) pylori antigen in a stool test at screening
- •Is diagnosed to have any gastric disease (macroscopic) as visually assessed by gastroscopy at screening
- •History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening
研究组 & 干预措施
Cohort 1: JNJ-67953964 or Placebo
Participants will receive JNJ-67953964 or matching placebo oral capsules once daily (QD) over 4 weeks (28 days).
干预措施: JNJ-67953964 (Drug)
Cohort 1: JNJ-67953964 or Placebo
Participants will receive JNJ-67953964 or matching placebo oral capsules once daily (QD) over 4 weeks (28 days).
干预措施: Placebo (Drug)
Cohort 2: JNJ-67953964 or Placebo
Participants in this cohort will receive JNJ-67953964 only or will be randomly assigned to receive JNJ-67953964 or matching placebo.
干预措施: JNJ-67953964 (Drug)
Cohort 2: JNJ-67953964 or Placebo
Participants in this cohort will receive JNJ-67953964 only or will be randomly assigned to receive JNJ-67953964 or matching placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants with Microscopic Signs of Parietal Cell Damage
时间窗: Day 28
Microscopic signs of parietal cell damage is defined as the any of the following observations to be present in at least 2 biopsy specimens collected during a gastroscopy session: greater than (\>) 25 percent (%) decrease in the number of parietal cells from baseline in the gastric biopsies at visit 4 or multifocal to diffuse parietal cell apoptosis or degeneration.
次要结局
- Percentage of Participants with a Gastroscopy Lanza Score Greater than or Equal to (>=) 2(Day 28)
- Percentage of Participants with Microscopic Signs of Ulcers or Erosions in the Gastric Biopsies(Day 28)
- Percentage of Participants with a Gastroscopy Lanza Score Equal to (=) 4(Day 28)
- Distribution of all Gastroscopy Lanza Scores(Day 28)
- Gastric pH Before and up to 4 Hours After Dosing(Day 1: Predose up to 4 hours postdose)
- Percentage of Participants with Adverse Events (AEs) and AEs Related to Upper Gastrointestinal Symptoms(Up to 15 Weeks)