Drug-Drug Interactions of JMKX003142 in Healthy Participants
2026年4月27日 更新者:Jemincare
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.
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.
研究概览
地位
尚未招聘
干预/治疗
研究类型
介入性
注册 (估计的)
112
阶段
- 阶段1
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
是的
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Cohort 1: To evaluate the effect of fluconazole on the pharmacokinetic (PK) profile of JMKX003142
|
3mg once daily (QD) on Day 1 and Day 7
400mg QD on Day 4, 200mg QD from Day 5 to Day 9
6mg QD from Day 8 to Day 25
6mg QD on Day 1 and Day 8
6mg QD on Day 1 and Day 10
|
|
实验性的:Cohort 2: To evaluate the effect of JMKX003142 on the PK profiles of Cocktail Substrates
|
3mg once daily (QD) on Day 1 and Day 7
6mg QD from Day 8 to Day 25
6mg QD on Day 1 and Day 8
6mg QD on Day 1 and Day 10
Midazolam Oral Solution 2mg, Rosuvastatin Calcium Tablets 5mg and Digoxin Tablets 0.25mg QD on Day 1, Day 8 and Day 21
|
|
实验性的:Cohort 3: To evaluate the effect of cyclosporine on the pharmacokinetic (PK) profile of JMKX003142
|
3mg once daily (QD) on Day 1 and Day 7
6mg QD from Day 8 to Day 25
6mg QD on Day 1 and Day 8
6mg QD on Day 1 and Day 10
100 mg twice daily (BID) from Day 4 to Day 9
|
|
实验性的:Cohort 4: To evaluate the effect of omeprazole on the pharmacokinetic (PK) profile of JMKX003142
|
3mg once daily (QD) on Day 1 and Day 7
6mg QD from Day 8 to Day 25
6mg QD on Day 1 and Day 8
6mg QD on Day 1 and Day 10
40mg QD from Day 4 to Day 8
|
|
实验性的:Cohort 5: To evaluate the effect of efavirenz on the pharmacokinetic (PK) profile of JMKX003142
|
3mg once daily (QD) on Day 1 and Day 7
6mg QD from Day 8 to Day 25
6mg QD on Day 1 and Day 8
6mg QD on Day 1 and Day 10
600mg QD from Day 4 to Day 12
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Maximum Plasma Concentration (Cmax) of JMKX003142 and its metabolites
大体时间:for 120 hours
|
for 120 hours
|
|
Area Under Curve (AUC) of JMKX003142 and its metabolites
大体时间:for 120 hours
|
for 120 hours
|
|
Maximum Plasma Concentration (Cmax) of Midazolam and its metabolites
大体时间:for 144 hours
|
for 144 hours
|
|
Area Under Curve (AUC) of of Midazolam and its metabolites
大体时间:for 144 hours
|
for 144 hours
|
|
Maximum Plasma Concentration (Cmax) of Rosuvastatin
大体时间:144 hours
|
144 hours
|
|
Area Under Curve (AUC) of of Rosuvastatin
大体时间:for 144 hours
|
for 144 hours
|
|
Maximum Plasma Concentration (Cmax) of Digoxin
大体时间:for 144 hours
|
for 144 hours
|
|
Area Under Curve (AUC) of Digoxin
大体时间:for 144 hours
|
for 144 hours
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Tmax of JMKX003142 and its metabolites
大体时间:for 120 hours
|
for 120 hours
|
|
T1/2 of JMKX003142 and its metabolites
大体时间:for 120 hours
|
for 120 hours
|
|
CL of JMKX003142 and its metabolites
大体时间:for 120 hours
|
for 120 hours
|
|
Tmax of Midazolam and its metabolites
大体时间:for 144 hours
|
for 144 hours
|
|
T1/2 of Midazolam and its metabolites
大体时间:for 144 hours
|
for 144 hours
|
|
CL of Midazolam and its metabolites
大体时间:for 144 hours
|
for 144 hours
|
|
Tmax of Rosuvastatin
大体时间:for 144 hours
|
for 144 hours
|
|
T1/2 of Rosuvastatin
大体时间:for 144 hours
|
for 144 hours
|
|
CL of Rosuvastatin
大体时间:for 144 hours
|
for 144 hours
|
|
Tmax of Digoxin
大体时间:for 144 hours
|
for 144 hours
|
|
T1/2 of Digoxin
大体时间:for 144 hours
|
for 144 hours
|
|
CL of Digoxin
大体时间:for 144 hours
|
for 144 hours
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年5月11日
初级完成 (估计的)
2026年11月15日
研究完成 (估计的)
2027年2月28日
研究注册日期
首次提交
2026年4月27日
首先提交符合 QC 标准的
2026年4月27日
首次发布 (实际的)
2026年5月4日
研究记录更新
最后更新发布 (实际的)
2026年5月4日
上次提交的符合 QC 标准的更新
2026年4月27日
最后验证
2026年4月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- JMKX003142-106
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.