a Single-center, Non-randomized, Open-label, Self-controlled Phase 1 Clinical Study to Evaluate Drug-drug Interactions of JMKX001899 Tablets in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 主要终点
- area under the curve from time 0 to the last time point (AUC0-t) for plasma
研究概览
简要总结
This is an open-label, non-randomized, clinical study to evaluate the drug interaction between itraconazole, rifampin or Cocktail and JMKX001899 in healthy subjects. A total of three cohorts of 72 healthy subjects were planned to be enrolled in each cohort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •voluntarily sign the informed consent, fully understand the content of the trial, and be able to complete the study according to the requirements of the trial protocol.
- •subjects aged 18 to 45 years (including both ends) at the time of signing informed consent.
- •male body weight is not less than 50 kg, female body weight is not less than 50 kg, and body mass index (BMI) is within the range of 19 ~ 27 kg/m2 (including cut-off value).
排除标准
- •hepatitis B surface antigen HBsAg positive, hepatitis C virus antibody positive, positive AIDS antigen/antibody or Treponema pallidum antibody.
- •Patients with a history of clinically significant diseases including, but not limited to, gastrointestinal, renal, liver, neurological, hematological, endocrine, neoplastic, pulmonary, immune, psychiatric, or cardiovascular and cerebrovascular diseases, epilepsy, bipolar disorder/mania, intraocular hypertension, or acute angle-closure glaucoma.
- •have taken any products containing caffeine, alcohol, grapefruit, and xanthine-rich within 24 hours before taking study medication.
研究组 & 干预措施
JMKX001899+Itraconazole
Enrolled subjects were treated with JMKX001899 on Day 1. Itraconazole was administered orally once daily after a standardized meal from Day 4 to Day 6. JMKX001899 and itraconazole were administered simultaneously after a standardized meal on Day 7. On Day 8 to Day 9, itraconazole was orally administered once after a standard meal
干预措施: JMKX001899 (Drug)
JMKX001899+Itraconazole
Enrolled subjects were treated with JMKX001899 on Day 1. Itraconazole was administered orally once daily after a standardized meal from Day 4 to Day 6. JMKX001899 and itraconazole were administered simultaneously after a standardized meal on Day 7. On Day 8 to Day 9, itraconazole was orally administered once after a standard meal
干预措施: Itraconazole (Drug)
JMKX001899+Rifampin
Enrolled subjects were treated with JMKX001899 after high fat meal on Day 1 and an empty stomach on Day 4. Rifampin was administered orally once daily on an empty stomac from Day 7 to Day 15, Day 17and Day 18. JMKX001899 and Rigampin were administered simultaneously on an empty stomach on Day 16.
干预措施: JMKX001899 (Drug)
JMKX001899+Rifampin
Enrolled subjects were treated with JMKX001899 after high fat meal on Day 1 and an empty stomach on Day 4. Rifampin was administered orally once daily on an empty stomac from Day 7 to Day 15, Day 17and Day 18. JMKX001899 and Rigampin were administered simultaneously on an empty stomach on Day 16.
干预措施: Rifampin (Drug)
JMKX001899+Cocktail substrate (Midazolam, dextromethorphan, Rosuvastatin and digoxin)
Enrolled subjects were treated with Cocktail substrate (Midazolam, dextromethorphan, Rosuvastatin and digoxin) on an empty stomach on Day 1. JMKX001899 was administered orally once daily after a standardized meal from Day 9 to Day 20 and Day 22. Cocktail and JMKX001899 were administered simultaneously on an empty stomach on Day 8 and Day 21.
干预措施: JMKX001899 (Drug)
JMKX001899+Cocktail substrate (Midazolam, dextromethorphan, Rosuvastatin and digoxin)
Enrolled subjects were treated with Cocktail substrate (Midazolam, dextromethorphan, Rosuvastatin and digoxin) on an empty stomach on Day 1. JMKX001899 was administered orally once daily after a standardized meal from Day 9 to Day 20 and Day 22. Cocktail and JMKX001899 were administered simultaneously on an empty stomach on Day 8 and Day 21.
干预措施: Midazolam (Drug)
JMKX001899+Cocktail substrate (Midazolam, dextromethorphan, Rosuvastatin and digoxin)
Enrolled subjects were treated with Cocktail substrate (Midazolam, dextromethorphan, Rosuvastatin and digoxin) on an empty stomach on Day 1. JMKX001899 was administered orally once daily after a standardized meal from Day 9 to Day 20 and Day 22. Cocktail and JMKX001899 were administered simultaneously on an empty stomach on Day 8 and Day 21.
干预措施: dextromethorphan (Drug)
JMKX001899+Cocktail substrate (Midazolam, dextromethorphan, Rosuvastatin and digoxin)
Enrolled subjects were treated with Cocktail substrate (Midazolam, dextromethorphan, Rosuvastatin and digoxin) on an empty stomach on Day 1. JMKX001899 was administered orally once daily after a standardized meal from Day 9 to Day 20 and Day 22. Cocktail and JMKX001899 were administered simultaneously on an empty stomach on Day 8 and Day 21.
干预措施: Rosuvastatin (Drug)
JMKX001899+Cocktail substrate (Midazolam, dextromethorphan, Rosuvastatin and digoxin)
Enrolled subjects were treated with Cocktail substrate (Midazolam, dextromethorphan, Rosuvastatin and digoxin) on an empty stomach on Day 1. JMKX001899 was administered orally once daily after a standardized meal from Day 9 to Day 20 and Day 22. Cocktail and JMKX001899 were administered simultaneously on an empty stomach on Day 8 and Day 21.
干预措施: digoxin (Drug)
结局指标
主要结局
area under the curve from time 0 to the last time point (AUC0-t) for plasma
时间窗: approximately 3 days after first dose
area under the curve from time 0 to infinity(AUC0-inf) for plasma
时间窗: approximately 3 days after first dose
maximum concentrations (Cmax ) for plasma
时间窗: approximately 3 days after first dose
次要结局
未报告次要终点