Drug-Drug Interactions of JMKX003142 in Healthy Participants

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.

Study Overview

• Status: Not yet recruiting
• Conditions: ADPKD (Autosomal Dominant Polycystic Kidney Disease)
• Intervention / Treatment: Drug: JMKX003142 tablets; Drug: Fluconazole Capsules; Drug: JMKX003142 tablets; Drug: JMKX003142 tablets; Drug: JMKX003142 tablets; Drug: Cocktail Substrates (Midazolam Oral Solution, Rosuvastatin Calcium Tablets, and Digoxin Tablets); Drug: Cyclosporine Soft Capsules; Drug: Omeprazole Enteric-coated Tablets; Drug: Efavirenz Tablets

• Study Type: Interventional
• Enrollment (Estimated): 112
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 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.
2. 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).
3. 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.
4. 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:

1. Known or suspected hypersensitivity to JMKX003142 (active ingredient or excipients), or a history of hypersensitivity to more than two drugs, foods, or other substances.
2. 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.
3. 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.
4. 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.
5. 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.
6. Positive for Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody, Human Immunodeficiency Virus (HIV) antibody, or syphilis serology.
7. 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).
8. Use of any investigational drug within 3 months prior to screening, or current participation in another clinical trial.
9. Major surgery (e.g., requiring general or epidural anesthesia) within 3 months prior to screening, or planned surgical intervention during the study.
10. History of hemophobia, belonephobia, or difficult venous access.
11. Blood donation or blood loss of ≥400 mL within 3 months prior to screening.
12. History of drug dependence/abuse or illicit drug use, or a positive drug screening result.
13. 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.
14. 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.
15. 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.
16. Ingestion of grapefruit or grapefruit-related citrus fruits (e.g., Seville oranges, pomelos) or fruit products within 3 days prior to dosing.
17. Special dietary requirements, or inability to comply with a standardized diet (e.g., standard meals) and dietary restrictions.
18. 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.
19. Requirement to drive long distances, work at heights, or operate complex machinery during the study.
20. Other conditions that, in the investigator's opinion, would make the subject unsuitable for participation in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: To evaluate the effect of fluconazole on the pharmacokinetic (PK) profile of JMKX003142	Drug: JMKX003142 tablets; 3mg once daily (QD) on Day 1 and Day 7; Drug: Fluconazole Capsules; 400mg QD on Day 4, 200mg QD from Day 5 to Day 9; Drug: JMKX003142 tablets; 6mg QD from Day 8 to Day 25; Drug: JMKX003142 tablets; 6mg QD on Day 1 and Day 8; Drug: JMKX003142 tablets; 6mg QD on Day 1 and Day 10
Experimental: Cohort 2: To evaluate the effect of JMKX003142 on the PK profiles of Cocktail Substrates	Drug: JMKX003142 tablets; 3mg once daily (QD) on Day 1 and Day 7; Drug: JMKX003142 tablets; 6mg QD from Day 8 to Day 25; Drug: JMKX003142 tablets; 6mg QD on Day 1 and Day 8; Drug: JMKX003142 tablets; 6mg QD on Day 1 and Day 10; Drug: Cocktail Substrates (Midazolam Oral Solution, Rosuvastatin Calcium Tablets, and Digoxin Tablets); Midazolam Oral Solution 2mg, Rosuvastatin Calcium Tablets 5mg and Digoxin Tablets 0.25mg QD on Day 1, Day 8 and Day 21
Experimental: Cohort 3: To evaluate the effect of cyclosporine on the pharmacokinetic (PK) profile of JMKX003142	Drug: JMKX003142 tablets; 3mg once daily (QD) on Day 1 and Day 7; Drug: JMKX003142 tablets; 6mg QD from Day 8 to Day 25; Drug: JMKX003142 tablets; 6mg QD on Day 1 and Day 8; Drug: JMKX003142 tablets; 6mg QD on Day 1 and Day 10; Drug: Cyclosporine Soft Capsules; 100 mg twice daily (BID) from Day 4 to Day 9
Experimental: Cohort 4: To evaluate the effect of omeprazole on the pharmacokinetic (PK) profile of JMKX003142	Drug: JMKX003142 tablets; 3mg once daily (QD) on Day 1 and Day 7; Drug: JMKX003142 tablets; 6mg QD from Day 8 to Day 25; Drug: JMKX003142 tablets; 6mg QD on Day 1 and Day 8; Drug: JMKX003142 tablets; 6mg QD on Day 1 and Day 10; Drug: Omeprazole Enteric-coated Tablets; 40mg QD from Day 4 to Day 8
Experimental: Cohort 5: To evaluate the effect of efavirenz on the pharmacokinetic (PK) profile of JMKX003142	Drug: JMKX003142 tablets; 3mg once daily (QD) on Day 1 and Day 7; Drug: JMKX003142 tablets; 6mg QD from Day 8 to Day 25; Drug: JMKX003142 tablets; 6mg QD on Day 1 and Day 8; Drug: JMKX003142 tablets; 6mg QD on Day 1 and Day 10; Drug: Efavirenz Tablets; 600mg QD from Day 4 to Day 12

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum Plasma Concentration (Cmax) of JMKX003142 and its metabolites	for 120 hours
Area Under Curve (AUC) of JMKX003142 and its metabolites	for 120 hours
Maximum Plasma Concentration (Cmax) of Midazolam and its metabolites	for 144 hours
Area Under Curve (AUC) of of Midazolam and its metabolites	for 144 hours
Maximum Plasma Concentration (Cmax) of Rosuvastatin	144 hours
Area Under Curve (AUC) of of Rosuvastatin	for 144 hours
Maximum Plasma Concentration (Cmax) of Digoxin	for 144 hours
Area Under Curve (AUC) of Digoxin	for 144 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Jemincare
• Collaborators: Zhejiang Hangyu Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): May 11, 2026
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: April 27, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ciliopathies; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genetic Diseases, Inborn; Congenital Abnormalities; Abnormalities, Multiple; Kidney Diseases, Cystic; Polycystic Kidney Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Polycystic Kidney, Autosomal Dominant; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Azoles; Carbohydrates; Polycyclic Compounds; Glycosides; Steroids; Fused-Ring Compounds; Benzazepines; Benzodiazepines; Triazoles; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Midazolam; Digoxin; Fluconazole; efavirenz
• Other Study ID Numbers: JMKX003142-106

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No