ADPKD (autosomal Dominant Polycystic Kidney Disease)Phase 1NCT06658964
Study to Evaluate the Drug-drug Interaction of JMKX003142 in Healthy Subjects
A Phase 1 study testing Cohort 1: JMKX003142 and itraconazole and Cohort 2: JMKX003142 and rifampicin in people with ADPKD (autosomal Dominant Polycystic Kidney Disease), run by Jemincare.
Trial summary
To evaluate the effects of oral administration rifampicin or itraconazole capsules on the pharmacokinetics of JMKX003142 in healthy subjects. 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?
- Cohort 1: JMKX003142 and itraconazole and Cohort 2: JMKX003142 and rifampicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 5 Nov 2024to 21 Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Fully understand the research content, process, and potential risks of this trial, voluntarily participate in the clinical trial and sign the informed consent,
- Healthy male and female subjects aged ≥18 years and ≤45 years old, Male weight ≥50kg, female weight ≥45kg, body mass index ≥19 kg/m2 and ≤28 kg/m2,
- The health of the subjects was determined by the investigator based on medical history, physical examination, clinical laboratory examination, and 12-lead electrocardiogram, all of which were determined by the investigator to be normal or not clinically significant.
Who cannot join
- HBV surface antigen, HCV antibody, HIV, or syphilis are positive during screening,
- At the time of screening, the vital signs are within the following ranges: systolic blood pressure <90 mmHg or >140 mmHg, diastolic blood pressure <50 mmHg or >90 mmHg, pulse <50 bpm or >100 bpm and ear temperature 37.5℃or<35℃,
- More than 5 cigarettes per day during the 3 months prior to screening, Or were unable to quit smoking/containing tobacco products during the trial,
- Have special requirements for diet and cannot comply with the diet provided and corresponding regulations.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Single-center, Non-randomized, Open-label, Self-controlled Phase 1 Clinical Study to Evaluate Drug-drug Interactions of JMKX003142 Tablets in Healthy Subjects
To evaluate the effects of oral administration rifampicin or itraconazole capsules on the pharmacokinetics of JMKX003142 in healthy subjects.
- Being tested
- Cohort 1: JMKX003142 and itraconazole, Cohort 2: JMKX003142 and rifampicin
- 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.
Cohort 1: JMKX003142 and itraconazoleDrug
JMKX003142: Dose: 3 mg, D1, once only in the morning. 3 mg JMKX003142 coadministered with 200 mg itraconazole once: Day8, once only in the morning.
Itraconazole：Dose: 200mg once；Day5-Day7 and Day9-Day11, QD
Cohort 2: JMKX003142 and rifampicinDrug
JMKX003142: Dose: 6 mg, D1, once only in the morning. 3 mg JMKX003142 coadministered with 200 mg rifampicin once: Day14, once only in the morning.
Rifampicin：Dose: 600mg once；Day5-Day13 and Day15-Day17, QD
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1：JMKX003142 and itraconazole | Experimental | Interaction between JMKX003142 and itraconazole Receives: Drug: Cohort 1: JMKX003142 and itraconazole |
| Cohort 2：JMKX003142 and rifampicin | Experimental | Interaction between JMKX003142 and rifampicin Receives: Drug: Cohort 2: JMKX003142 and rifampicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of JMKX003142 in plasma
Cmax of JMKX003142 when JMKX003142 administered with or without itraconazole/rifampicin
Measured: approximately 5 days after JMKX003142 administered
AUC of JMKX003142 in plasma
AUC of JMKX003142 when JMKX003142 administered with or without itraconazole/rifampicin
Measured: approximately 5 days after JMKX003142 administered
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start5 Nov 2024 (estimated)
- Primary completion10 Dec 2024 (estimated)
- Study completion21 Mar 2025 (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
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jemincare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zhejiang Hangyu Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Leilei Zhu, Principal investigator, Shuguang Hospital Affiliated with Shanghai University of TCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658964
- Sponsor's protocol ID
- JMKX003142-102
- Status last verified
- Oct 2024
- First submitted
- 23 Oct 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. 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 1 Clinical Study to Evaluate Drug-drug Interactions of JMKX003142 Tablets in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06658964
- Acronym / sponsor ID
- JMKX003142-102
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- JemincareIndustry (pharma, biotech, devices)
- Collaborators
- Zhejiang Hangyu Pharmaceutical Co., Ltd.
- Study start
- 5 Nov 2024 (estimated)
- Primary completion
- 10 Dec 2024 (estimated)
- Study completion
- 21 Mar 2025 (estimated)
- First posted
- 26 Oct 2024 (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.
To evaluate the effects of oral administration rifampicin or itraconazole capsules on the pharmacokinetics of JMKX003142 in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1：JMKX003142 and itraconazole | Experimental | Drug: Cohort 1: JMKX003142 and itraconazoleInteraction between JMKX003142 and itraconazole |
| Cohort 2：JMKX003142 and rifampicin | Experimental | Drug: Cohort 2: JMKX003142 and rifampicinInteraction between JMKX003142 and rifampicin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Fully understand the research content, process, and potential risks of this trial, voluntarily participate in the clinical trial and sign the informed consent,
- Healthy male and female subjects aged ≥18 years and ≤45 years old, Male weight ≥50kg, female weight ≥45kg, body mass index ≥19 kg/m2 and ≤28 kg/m2,
- The health of the subjects was determined by the investigator based on medical history, physical examination, clinical laboratory examination, and 12-lead electrocardiogram, all of which were determined by the investigator to be normal or not clinically significant.
Key exclusion criteria (4 listed)
- HBV surface antigen, HCV antibody, HIV, or syphilis are positive during screening,
- At the time of screening, the vital signs are within the following ranges: systolic blood pressure <90 mmHg or >140 mmHg, diastolic blood pressure <50 mmHg or >90 mmHg, pulse <50 bpm or >100 bpm and ear temperature 37.5℃or<35℃,
- More than 5 cigarettes per day during the 3 months prior to screening, Or were unable to quit smoking/containing tobacco products during the trial,
- Have special requirements for diet and cannot comply with the diet provided and corresponding regulations.
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 |
|---|---|---|
| Cohort 1: JMKX003142 and itraconazoleJMKX003142: Dose: 3 mg, D1, once only in the morning. 3 mg JMKX003142 coadministered with 200 mg itraconazole once: Day8, once only in the morning. Itraconazole：Dose: 200mg once；Day5-Day7 and Day9-Day11, QD | Drug | Cohort 1：JMKX003142 and itraconazole |
| Cohort 2: JMKX003142 and rifampicinJMKX003142: Dose: 6 mg, D1, once only in the morning. 3 mg JMKX003142 coadministered with 200 mg rifampicin once: Day14, once only in the morning. Rifampicin：Dose: 600mg once；Day5-Day13 and Day15-Day17, QD | Drug | Cohort 2：JMKX003142 and rifampicin |
Primary outcome
Cmax of JMKX003142 in plasma
Time frame: approximately 5 days after JMKX003142 administered
Cmax of JMKX003142 when JMKX003142 administered with or without itraconazole/rifampicin
AUC of JMKX003142 in plasma
Time frame: approximately 5 days after JMKX003142 administered
AUC of JMKX003142 when JMKX003142 administered with or without itraconazole/rifampicin
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
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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. This study is not recruiting at the moment.
Leilei Zhu principal investigator
Shuguang Hospital Affiliated with Shanghai University of TCM
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cohort 1: JMKX003142 and itraconazole and Cohort 2: JMKX003142 and rifampicin in people with ADPKD (autosomal Dominant Polycystic Kidney Disease), run by Jemincare.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 26 Oct 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianping Su (86+15162481262, sujianping@jemincare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax of JMKX003142 in plasma (time frame: approximately 5 days after JMKX003142 administered). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2024.