ADPKD (Autosomal Dominant Polycystic Kidney Disease)Phase 1NCT07565441

Drug-Drug Interactions of JMKX003142 in Healthy Participants

A Phase 1 study testing JMKX003142 tablets, Fluconazole Capsules and Cocktail Substrates (Midazolam Oral Solution, Rosuvastatin Calcium Tablets, and Digoxin Tablets) in people with ADPKD (Autosomal Dominant Polycystic Kidney Disease), run by Jemincare.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: ADPKD (Autosomal Dominant Polycystic Kidney Disease)
What is being tested?: JMKX003142 tablets, Fluconazole Capsules and Cocktail Substrates (Midazolam Oral Solution, Rosuvastatin Calcium Tablets, and Digoxin Tablets)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 112 participants
Where: No sites listed yet
Study dates: 11 May 2026to 28 Feb 2027
Phase: Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

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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.

About this study

Official title: 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.

Conditions: ADPKD (Autosomal Dominant Polycystic Kidney Disease)
Being tested: JMKX003142 tablets, Fluconazole Capsules, Cocktail Substrates (Midazolam Oral Solution, Rosuvastatin Calcium Tablets, and Digoxin Tablets), Cyclosporine Soft Capsules, Omeprazole Enteric-coated Tablets
Medical subject headings: Polycystic Kidney, Autosomal Dominant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

JMKX003142 tabletsDrug
3mg once daily (QD) on Day 1 and Day 7
Fluconazole CapsulesDrug
400mg QD on Day 4, 200mg QD from Day 5 to Day 9
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
Cyclosporine Soft CapsulesDrug
100 mg twice daily (BID) from Day 4 to Day 9
Omeprazole Enteric-coated TabletsDrug
40mg QD from Day 4 to Day 8
Efavirenz TabletsDrug
600mg QD from Day 4 to Day 12
JMKX003142 tabletsDrug
6mg QD from Day 8 to Day 25
JMKX003142 tabletsDrug
6mg QD on Day 1 and Day 8
JMKX003142 tabletsDrug
6mg QD on Day 1 and Day 10

Study groups in NCT07565441
Study group	Role	What they receive
Cohort 1: To evaluate the effect of fluconazole on the pharmacokinetic (PK) profile of JMKX003142	Experimental	Not described Receives: Drug: JMKX003142 tablets; Drug: Fluconazole Capsules
Cohort 2: To evaluate the effect of JMKX003142 on the PK profiles of Cocktail Substrates	Experimental	Not described Receives: 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	Not described Receives: Drug: JMKX003142 tablets; Drug: Cyclosporine Soft Capsules
Cohort 4: To evaluate the effect of omeprazole on the pharmacokinetic (PK) profile of JMKX003142	Experimental	Not described Receives: Drug: Omeprazole Enteric-coated Tablets; Drug: JMKX003142 tablets
Cohort 5: To evaluate the effect of efavirenz on the pharmacokinetic (PK) profile of JMKX003142	Experimental	Not described Receives: Drug: Efavirenz Tablets; Drug: JMKX003142 tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Plasma Concentration (Cmax) of JMKX003142 and its metabolites
Measured: for 120 hours
Area Under Curve (AUC) of JMKX003142 and its metabolites
Measured: for 120 hours
Maximum Plasma Concentration (Cmax) of Midazolam and its metabolites
Measured: for 144 hours
Area Under Curve (AUC) of of Midazolam and its metabolites
Measured: for 144 hours
Maximum Plasma Concentration (Cmax) of Rosuvastatin
Measured: 144 hours
Area Under Curve (AUC) of of Rosuvastatin
Measured: for 144 hours
Maximum Plasma Concentration (Cmax) of Digoxin
Measured: for 144 hours
Area Under Curve (AUC) of Digoxin
Measured: for 144 hours

Secondary outcomes (12)

Tmax of JMKX003142 and its metabolites
Measured: for 120 hours
T1/2 of JMKX003142 and its metabolites
Measured: for 120 hours
CL of JMKX003142 and its metabolites
Measured: for 120 hours
Tmax of Midazolam and its metabolites
Measured: for 144 hours
T1/2 of Midazolam and its metabolites
Measured: for 144 hours
CL of Midazolam and its metabolites
Measured: for 144 hours
Tmax of Rosuvastatin
Measured: for 144 hours
T1/2 of Rosuvastatin
Measured: for 144 hours
CL of Rosuvastatin
Measured: for 144 hours
Tmax of Digoxin
Measured: for 144 hours
T1/2 of Digoxin
Measured: for 144 hours
CL of Digoxin
Measured: for 144 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 May 202628 Feb 2027

First posted4 May 2026
Study start11 May 2026 (estimated)
Primary completion15 Nov 2026 (estimated)
Study completion28 Feb 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ADPKD (Autosomal Dominant Polycystic Kidney Disease)Studies of the same condition, open and under way.
More trials run by JemincareThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 112 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07565441
Sponsor's protocol ID: JMKX003142-106
Status last verified: Apr 2026
First submitted: 27 Apr 2026
Last updated: 4 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All ADPKD (Autosomal Dominant Polycystic Kidney Disease) trials

Study at a glance

From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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.
ClinicalTrials.gov ID: NCT07565441
Acronym / sponsor ID: JMKX003142-106
Conditions: ADPKD (Autosomal Dominant Polycystic Kidney Disease)
Phase: Phase 1
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 112 participants (estimated)
Lead sponsor: JemincareIndustry (pharma, biotech, devices)
Collaborators: Zhejiang Hangyu Pharmaceutical Co., Ltd.
Study start: 11 May 2026 (estimated)
Primary completion: 15 Nov 2026 (estimated)
Study completion: 28 Feb 2027 (estimated)
First posted: 4 May 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
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

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (20 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
JMKX003142 tablets3mg once daily (QD) on Day 1 and Day 7	Drug	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
Fluconazole Capsules400mg QD on Day 4, 200mg QD from Day 5 to Day 9	Drug	Cohort 1: To evaluate the effect of fluconazole on the pharmacokinetic (PK) profile of JMKX003142
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	Drug	Cohort 2: To evaluate the effect of JMKX003142 on the PK profiles of Cocktail Substrates
Cyclosporine Soft Capsules100 mg twice daily (BID) from Day 4 to Day 9	Drug	Cohort 3: To evaluate the effect of cyclosporine on the pharmacokinetic (PK) profile of JMKX003142
Omeprazole Enteric-coated Tablets40mg QD from Day 4 to Day 8	Drug	Cohort 4: To evaluate the effect of omeprazole on the pharmacokinetic (PK) profile of JMKX003142
Efavirenz Tablets600mg QD from Day 4 to Day 12	Drug	Cohort 5: To evaluate the effect of efavirenz on the pharmacokinetic (PK) profile of JMKX003142
JMKX003142 tablets6mg QD from Day 8 to Day 25	Drug	Cohort 2: To evaluate the effect of JMKX003142 on the PK profiles of Cocktail Substrates
JMKX003142 tablets6mg QD on Day 1 and Day 8	Drug	Cohort 4: To evaluate the effect of omeprazole on the pharmacokinetic (PK) profile of JMKX003142
JMKX003142 tablets6mg QD on Day 1 and Day 10	Drug	Cohort 5: To evaluate the effect of efavirenz on the pharmacokinetic (PK) profile of JMKX003142

Primary outcome

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

12 secondary outcomes

Tmax of JMKX003142 and its metabolites
Time frame: for 120 hours
T1/2 of JMKX003142 and its metabolites
Time frame: for 120 hours
CL of JMKX003142 and its metabolites
Time frame: for 120 hours
Tmax of Midazolam and its metabolites
Time frame: for 144 hours
T1/2 of Midazolam and its metabolites
Time frame: for 144 hours
CL of Midazolam and its metabolites
Time frame: for 144 hours
Tmax of Rosuvastatin
Time frame: for 144 hours
T1/2 of Rosuvastatin
Time frame: for 144 hours
CL of Rosuvastatin
Time frame: for 144 hours
Tmax of Digoxin
Time frame: for 144 hours
T1/2 of Digoxin
Time frame: for 144 hours
CL of Digoxin
Time frame: for 144 hours

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.

Related trials for ADPKD (Autosomal Dominant Polycystic Kidney Disease)

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Plasma Concentration (Cmax) of JMKX003142 and its metabolites (time frame: for 120 hours). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07565441.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.