Drug-Drug Interactions of JMKX003142 in Healthy Participants

NCT07565441 | Not Yet Recruiting Phase 1

• 1 other identifier: JMKX003142-106
• Study Type: interventional
• Target: 112
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

ADPKD (Autosomal Dominant Polycystic Kidney Disease)

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (12)

• 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

Study Arms (5)

Cohort 1: To evaluate the effect of fluconazole on the pharmacokinetic (PK) profile of JMKX003142

EXPERIMENTAL

Drug: JMKX003142 tablets; Drug: Fluconazole Capsules

Cohort 2: To evaluate the effect of JMKX003142 on the PK profiles of Cocktail Substrates

EXPERIMENTAL

Drug: Cocktail Substrates (Midazolam Oral Solution, Rosuvastatin Calcium Tablets, and Digoxin Tablets); Drug: JMKX003142 tablets

Cohort 3: To evaluate the effect of cyclosporine on the pharmacokinetic (PK) profile of JMKX003142

EXPERIMENTAL

Drug: JMKX003142 tablets; Drug: Cyclosporine Soft Capsules

Cohort 4: To evaluate the effect of omeprazole on the pharmacokinetic (PK) profile of JMKX003142

EXPERIMENTAL

Drug: Omeprazole Enteric-coated Tablets; Drug: JMKX003142 tablets

Cohort 5: To evaluate the effect of efavirenz on the pharmacokinetic (PK) profile of JMKX003142

EXPERIMENTAL

Drug: Efavirenz Tablets; Drug: JMKX003142 tablets

Interventions

Fluconazole Capsules DRUG

400mg QD on Day 4, 200mg QD from Day 5 to Day 9

Cohort 1: To evaluate the effect of fluconazole on the pharmacokinetic (PK) profile of JMKX003142

Cyclosporine Soft Capsules DRUG

100 mg twice daily (BID) from Day 4 to Day 9

Cohort 3: To evaluate the effect of cyclosporine on the pharmacokinetic (PK) profile of JMKX003142

Efavirenz Tablets DRUG

600mg QD from Day 4 to Day 12

Cohort 5: To evaluate the effect of efavirenz on the pharmacokinetic (PK) profile of JMKX003142

Cocktail Substrates (Midazolam Oral Solution, Rosuvastatin Calcium Tablets, and Digoxin Tablets) DRUG

Midazolam Oral Solution 2mg, Rosuvastatin Calcium Tablets 5mg and Digoxin Tablets 0.25mg QD on Day 1, Day 8 and Day 21

Cohort 2: To evaluate the effect of JMKX003142 on the PK profiles of Cocktail Substrates

Omeprazole Enteric-coated Tablets DRUG

40mg QD from Day 4 to Day 8

Cohort 4: To evaluate the effect of omeprazole on the pharmacokinetic (PK) profile of JMKX003142

JMKX003142 tablets DRUG

3mg once daily (QD) on Day 1 and Day 7

Cohort 1: To evaluate the effect of fluconazole on the pharmacokinetic (PK) profile of JMKX003142; Cohort 3: To evaluate the effect of cyclosporine on the pharmacokinetic (PK) profile of JMKX003142

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jemincare: lead
• Zhejiang Hangyu Pharmaceutical Co., Ltd.: collaborator

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Interventions

Fluconazole; Midazolam; Digoxin; efavirenz

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 4, 2026
• Study Start (Estimated): May 11, 2026
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04