A Phase 1, Single and Multiple-Dose, Open-Label Study in Healthy Subjects to Assess the Effect of the Acid Reducing Agents, Omeprazole (OME) and Famotidine (FAM), on the Pharmacokinetics (PK) of Cenicriviroc Mesylate (CVC)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Pharmacokinetic Assessment of CVC, as measured by maximum plasma concentration (Cmax)
研究概览
简要总结
This is a Phase 1, Single and Multiple-Dose, Open-Label Study in Healthy Subjects to Assess the Effect of the Acid Reducing Agents, Omeprazole and Famotidine, on the PK of CVC
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Be informed of the nature of the study and have provided written informed voluntary consent.
- •Have a BMI ≥ 18.0 and ≤ 35.0 kg/m
- •Be in good general health with no clinically relevant abnormalities based on medical history, physical examination, clinical laboratory evaluations (clinical chemistry, hematology, urinalysis), and 12-lead ECG that, in the opinion of the Investigator, would affect subject safety.
- •Be able to communicate effectively with the Investigator and other study center personnel and agree to comply with the study procedures and restrictions.
排除标准
- •Any disease or condition that might affect drug absorption, metabolism, or excretion, or clinically significant cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, gastrointestinal, immunological, dermatological, neurological, or psychiatric disease, as determined by the Investigator and, if necessary, the Sponsor's Medical Monitor.
- •History of stomach or intestinal surgery, except for fully healed appendectomy and/or cholecystectomy which will be allowed.
- •Clinically significant illness or clinically significant surgery within 4 weeks before the administration of study medication.
- •History of GERD, heartburn, or nausea more than once a month, or any similar symptoms requiring the regular use of antacids, or any use of H2 histamine blockers or proton-pump inhibitors over the past 3 months.
- •History of achlorhydria, pernicious anemia, or peptic ulcers over the past 6 months.
- •Have a positive Helicobacter pylori urea breath test.
- •Known or suspected hypersensitivity or allergic reaction to any of the components of CVC, OME or FAM tablets.
- •History of malignancy, with the exception of cured basal cell or squamous cell carcinoma of the skin.
- •If female, is pregnant or breast feeding, or has a positive pregnancy test result prior to the first dose of study medication.
研究组 & 干预措施
Part 1 Group 1 (Cenicriviroc)
Part 1 Group 1 (12 subjects) will receive CVC 150 mg on Days 1, 7 and 13.
干预措施: Cenicriviroc (Drug)
Part 1 Group 1 (Omeprazole)
Part 1 Group 1 (12 subjects) will receive Omeprazole 20 mg from Days 2-7, and Omeprazole 40 mg from Days 8-13.
干预措施: Omeprazole (Drug)
Part 1 Group 2 (Cenicriviroc)
Part 1 Group 2 (12 subjects) will receive CVC 150 mg on Days 1, 5, 9 and 13.
干预措施: Cenicriviroc (Drug)
Part 1 Group 2 (Famotidine)
Part 1 Group 2 (12 subjects) will receive Famotidine 40 mg on Days 5, 9 and 13.
干预措施: Famotidine (Drug)
Part 2 (Cenicriviroc)
Part 2 (24 subjects) will receive Cenicriviroc from Days 1-10 and Days 11-20.
干预措施: Cenicriviroc (Drug)
Part 2 (Omeprazole)
Part 2 (24 subjects) will receive Omeprazole from Days 11-20.
干预措施: Omeprazole (Drug)
结局指标
主要结局
Pharmacokinetic Assessment of CVC, as measured by maximum plasma concentration (Cmax)
时间窗: Days 1, 7, and 13 for Part 1 Group 1. Days 1, 5, 9, and 13 for Part 1 Group 2.
Pharmacokinetic Assessment of CVC, as measured by minimum plasma concentration (Cmin)
时间窗: Days 1, 7, and 13 for Part 1 Group 1. Days 1, 5, 9, and 13 for Part 1 Group 2.
Pharmacokinetic Assessment of CVC, as measured by area under the plasma concentration-time curve (AUC)
时间窗: Days 1, 7, and 13 for Part 1 Group 1. Days 1, 5, 9, and 13 for Part 1 Group 2.
次要结局
- Changes from Baseline in 12-lead ECGs(Baseline and 23 days)
- Changes from Baseline in Vital Signs(Baseline and 23 days)
- Evaluation of Adverse Events(23 days)
- Changes from Baseline in Physical Examinations(Baseline and 23 days)
- Changes from Baseline in Clinical Laboratory Tests(Baseline and 23 days)