NCT07565441尚未招募1 期
A Single-center, Non-randomized, Open-label, Self-controlled, Phase I Clinical Study to Evaluate Drug-Drug Interactions (DDI) of JMKX003142 Tablets in Chinese Healthy Participants.
Jemincare0 个研究点目标入组 112 人开始时间: 2026年5月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 112
- 主要终点
- Maximum Plasma Concentration (Cmax) of JMKX003142 and its metabolites
研究概览
简要总结
This is a single-center, non-randomized, open-label, self-controlled, Phase I clinical trial to evaluate the drug-drug interactions (DDI) of JMKX003142 tablets in healthy adult participants.
The study consists of five cohorts (Cohorts 1, 2, 3, 4, and 5). A total of 24 participants are planned enrollment in each of Cohorts 1, 2, 3, and 5, while 16 participants are planned for Cohort 4.
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
- •Participants are able to return to the study center for follow-up as required by the protocol and are willing to comply with study policies, procedures, and restrictions; capable of effective communication with the investigator and completing study-related materials; able to understand the contents of the Informed Consent Form (ICF) and sign the written ICF prior to any study procedures.
- •Healthy Chinese male or female subjects, as determined by medical history and physical examination. At the time of signing the Informed Consent Form (ICF), aged 18-45 years (inclusive) ; body weight ≥ 50 kg for males or ≥ 45 kg for females; and Body Mass Index (BMI) within the range of 19.0-26.0 kg/m² (inclusive).
- •Participants were considered healthy by the Investigator based on medical history, baseline physical examination, clinical laboratory assessments, and 12-lead ECG, with all results judged as normal or not clinically significant.
- •Participants of childbearing potential who agree to use effective contraception and have no plans for conception, cryopreservation, or donation of gametes from ICF signature through 3 months after the last dose.
排除标准
- •Known or suspected hypersensitivity to JMKX003142 (active ingredient or excipients), or a history of hypersensitivity to more than two drugs, foods, or other substances.
- •History or presence of clinically significant diseases in any of the following systems (including but not limited to): cardiovascular, respiratory, gastrointestinal, hematologic, genitourinary, endocrine/metabolic, nervous, psychiatric, musculoskeletal, dermatologic, lymphatic, immune, or sensory organs; or current active local or systemic infection.
- •Any condition increasing the risk of bleeding, such as acute gastritis, active ulcer with hemorrhage, clinically significant thrombocytopenia or anemia, active pathological bleeding, or a history of intracranial hemorrhage.
- •Vital signs meet any of the following criteria at screening: systolic blood pressure ≥ 140 mmHg or < 90 mmHg; diastolic blood pressure ≥ 90 mmHg or < 50 mmHg; pulse rate > 100 bpm or < 50 bpm; or tympanic temperature ≥ 37.5°C or < 35°C.
- •Subjects with a history of QTc interval prolongation or a family history of Long QT Syndrome; or those with clinically significant abnormal ECG findings as determined by the Investigator during screening; or a QTcF ≥ 450 ms; or a QRS interval > 120 ms.
- •Positive for Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody, Human Immunodeficiency Virus (HIV) antibody, or syphilis serology.
- •Treatment with therapeutic biological products within 3 months (or 5 half-lives, whichever is longer) prior to dosing, or other prescription/non-prescription medications (including vaccines, Traditional Chinese Medicine [TCM], dietary supplements, and health products) within 1 month (or 5 half-lives, whichever is longer).
- •Use of any investigational drug within 3 months prior to screening, or current participation in another clinical trial.
- •Major surgery (e.g., requiring general or epidural anesthesia) within 3 months prior to screening, or planned surgical intervention during the study.
- •History of hemophobia, belonephobia, or difficult venous access.
- •Blood donation or blood loss of ≥400 mL within 3 months prior to screening.
- •History of drug dependence/abuse or illicit drug use, or a positive drug screening result.
- •Smoking ≥5 cigarettes per day within 3 months prior to screening, or inability to commit to abstaining from tobacco products during the study, or a positive nicotine screening result.
- •History of heavy alcohol consumption (>14 units per week; 1 unit ≈ 10 mL alcohol, equivalent to approx. 285 mL beer [3.5%], 25 mL spirits [40%], or 100 mL wine [10%]), inability to abstain from alcohol after screening, or a positive alcohol breath test.
- •Daily consumption of excessive tea, coffee, or caffeine-containing beverages (more than 8 cups per day; 1 cup = 250 mL) within 14 days prior to screening.
- •Ingestion of grapefruit or grapefruit-related citrus fruits (e.g., Seville oranges, pomelos) or fruit products within 3 days prior to dosing.
- •Special dietary requirements, or inability to comply with a standardized diet (e.g., standard meals) and dietary restrictions.
- •Pregnancy or lactation, positive pregnancy test in females, unprotected sexual intercourse with a partner within 14 days prior to screening, use of oral contraceptives within 30 days prior to screening, or use of long-acting injectable or implanted estrogens/progestogens within 6 months prior to screening.
- •Requirement to drive long distances, work at heights, or operate complex machinery during the study.
- •Other conditions that, in the investigator's opinion, would make the subject unsuitable for participation in this study.
研究组 & 干预措施
Cohort 2: To evaluate the effect of JMKX003142 on the PK profiles of Cocktail Substrates
Experimental
干预措施: Cocktail Substrates (Midazolam Oral Solution, Rosuvastatin Calcium Tablets, and Digoxin Tablets) (Drug)
Cohort 2: To evaluate the effect of JMKX003142 on the PK profiles of Cocktail Substrates
Experimental
干预措施: JMKX003142 tablets (Drug)
Cohort 3: To evaluate the effect of cyclosporine on the pharmacokinetic (PK) profile of JMKX003142
Experimental
干预措施: JMKX003142 tablets (Drug)
Cohort 3: To evaluate the effect of cyclosporine on the pharmacokinetic (PK) profile of JMKX003142
Experimental
干预措施: Cyclosporine Soft Capsules (Drug)
Cohort 4: To evaluate the effect of omeprazole on the pharmacokinetic (PK) profile of JMKX003142
Experimental
干预措施: Omeprazole Enteric-coated Tablets (Drug)
Cohort 4: To evaluate the effect of omeprazole on the pharmacokinetic (PK) profile of JMKX003142
Experimental
干预措施: JMKX003142 tablets (Drug)
Cohort 1: To evaluate the effect of fluconazole on the pharmacokinetic (PK) profile of JMKX003142
Experimental
干预措施: JMKX003142 tablets (Drug)
Cohort 1: To evaluate the effect of fluconazole on the pharmacokinetic (PK) profile of JMKX003142
Experimental
干预措施: Fluconazole Capsules (Drug)
Cohort 5: To evaluate the effect of efavirenz on the pharmacokinetic (PK) profile of JMKX003142
Experimental
干预措施: Efavirenz Tablets (Drug)
Cohort 5: To evaluate the effect of efavirenz on the pharmacokinetic (PK) profile of JMKX003142
Experimental
干预措施: JMKX003142 tablets (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax) of JMKX003142 and its metabolites
时间窗: for 120 hours
Area Under Curve (AUC) of JMKX003142 and its metabolites
时间窗: for 120 hours
Maximum Plasma Concentration (Cmax) of Midazolam and its metabolites
时间窗: for 144 hours
Area Under Curve (AUC) of of Midazolam and its metabolites
时间窗: for 144 hours
Maximum Plasma Concentration (Cmax) of Rosuvastatin
时间窗: 144 hours
Area Under Curve (AUC) of of Rosuvastatin
时间窗: for 144 hours
Maximum Plasma Concentration (Cmax) of Digoxin
时间窗: for 144 hours
Area Under Curve (AUC) of Digoxin
时间窗: for 144 hours
次要结局
- Tmax of JMKX003142 and its metabolites(for 120 hours)
- T1/2 of JMKX003142 and its metabolites(for 120 hours)
- CL of JMKX003142 and its metabolites(for 120 hours)
- Tmax of Midazolam and its metabolites(for 144 hours)
- T1/2 of Midazolam and its metabolites(for 144 hours)
- CL of Midazolam and its metabolites(for 144 hours)
- Tmax of Rosuvastatin(for 144 hours)
- T1/2 of Rosuvastatin(for 144 hours)
- CL of Rosuvastatin(for 144 hours)
- Tmax of Digoxin(for 144 hours)
- T1/2 of Digoxin(for 144 hours)
- CL of Digoxin(for 144 hours)
研究者
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