New drug interaction study launches for polycystic kidney disease treatment
NCT ID NCT07565441
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This early-stage study tests how a new drug called JMKX003142 interacts with other common medications in 112 healthy Chinese adults. The drug is being developed for autosomal dominant polycystic kidney disease (ADPKD). Researchers will measure how the body processes JMKX003142 when taken with drugs like fluconazole, cyclosporine, and omeprazole. The results will help determine safe dosing for future patient studies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- JMKX003142 tablets
- What this could lead to
- If successful, this study will show how JMKX003142 interacts with other drugs, helping doctors choose safe doses for future ADPKD patients.
- What could go wrong
- This is an early Phase 1 trial in healthy people, not patients. It only checks drug interactions, not whether JMKX003142 works for ADPKD. Results may not predict real-world effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 112 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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