HealthyPhase 1NCT06066060
A DDI Study of JMKX000623 and Metformin Hydrochloride
A Phase 1 study testing JMKX000623 and Metformin in people with Healthy and Drug-Drug Interaction, run by Jemincare at 1 site in China.
Trial summary
A phase 1, single center, 1 sequence, 3 period, open label, multiple doses study to evaluate the drug-drug interaction of JMKX000623 tablet and metformin. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Healthy, Drug-Drug Interaction
- What is being tested?
- JMKX000623 and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 17 Sep 2023to 6 Nov 2023
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Healthy Chinese subjects aged 18-45 years, male or female;
- Weight: male≥50.0kg, female≥45.0kg, 19.0 kg/m2≤BMI<27.0 kg/m2;
- Normal or abnormal but without clinical significance reports of physical examinations, vital signs, clinical laboratory tests and others;
- Able to provide written informed consent voluntarily.
Who cannot join
- Suspected hypersensitivity to the main ingredients and excipients of JMKX000623 tablets, metformin hydrochloride tablets, or a history of allergy to drugs, food or other substances;
- History of clinically significant chronic gastrointestinal disease or history of gastrointestinal surgery (excluding appendectomy) that the investigator believes may affect drug absorption;
- Surgery within 3 months prior to screening that, in the judgment of the investigator, would interfere with the absorption, distribution, metabolism, or excretion of the drug, or surgery within 4 weeks prior to the use of the investigational drug, or planned surgery during the research;
- Took any prescription, over-the-counter, and herbal medications within 2 weeks prior to screening, or were within 5 half-lives of the medication at the time of screening, and plan to take other experimental medications other than those in this study for the duration of the research;
- Other conditions unsuitable for the study confirmed by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study to Evaluate the Drug-Drug Interaction (DDI) Between JMKX000623 Tablets and Metformin Hydrochloride Tablets in Healthy Chinese Subjects
A phase 1, single center, 1 sequence, 3 period, open label, multiple doses study to evaluate the drug-drug interaction of JMKX000623 tablet and metformin.
Read the detailed description
The drug-drug interaction study is meant to evaluate the pharmacokinetics and safety of JMKX000623 tablet combined metformin in healthy volunteers
- Conditions
- Healthy, Drug-Drug Interaction
- Being tested
- JMKX000623, Metformin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JMKX000623Drug
JMKX000623, administered orally ;
MetforminDrug
Metformin,administered orally
| Study group | Role | What they receive |
|---|---|---|
| JMKX000623/Metformin/ JMKX000623+Metformin | Experimental | D1-D8, JMKX000623; D14-D19, Metformin; D20-D27, JMKX000623+Metformin Receives: Drug: JMKX000623; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Dosing Time Curve During the Dosing Interval After Reaching Steady State（AUC0-tau）
Measured: baseline through 4 days post-dose
Maximum observed After Reaching steady state concentration (Css,max)
Measured: baseline through 4 days post-dose
Secondary outcomes (1)
Adverse events (AEs)
Incidence and features of AEs assessed by CTCAE v5.0.
Measured: baseline through 4 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start17 Sep 2023
- Primary completion6 Nov 2023
- Study completion6 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jemincare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaojie Wu, MD, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06066060
- Sponsor's protocol ID
- JY-JM025-102
- Status last verified
- Apr 2024
- First submitted
- 13 Sep 2023
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study to Evaluate the Drug-Drug Interaction (DDI) Between JMKX000623 Tablets and Metformin Hydrochloride Tablets in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT06066060
- Acronym / sponsor ID
- JY-JM025-102
- Conditions
- Healthy, Drug-Drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- JemincareIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2023 (actual)
- Primary completion
- 6 Nov 2023 (actual)
- Study completion
- 6 Nov 2023 (actual)
- First posted
- 4 Oct 2023 (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.
A phase 1, single center, 1 sequence, 3 period, open label, multiple doses study to evaluate the drug-drug interaction of JMKX000623 tablet and metformin.
Detailed description
The drug-drug interaction study is meant to evaluate the pharmacokinetics and safety of JMKX000623 tablet combined metformin in healthy volunteers
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JMKX000623/Metformin/ JMKX000623+Metformin | Experimental | Drug: JMKX000623, Drug: MetforminD1-D8, JMKX000623; D14-D19, Metformin; D20-D27, JMKX000623+Metformin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy Chinese subjects aged 18-45 years, male or female;
- Weight: male≥50.0kg, female≥45.0kg, 19.0 kg/m2≤BMI<27.0 kg/m2;
- Normal or abnormal but without clinical significance reports of physical examinations, vital signs, clinical laboratory tests and others;
- Able to provide written informed consent voluntarily.
Key exclusion criteria (5 listed)
- Suspected hypersensitivity to the main ingredients and excipients of JMKX000623 tablets, metformin hydrochloride tablets, or a history of allergy to drugs, food or other substances;
- History of clinically significant chronic gastrointestinal disease or history of gastrointestinal surgery (excluding appendectomy) that the investigator believes may affect drug absorption;
- Surgery within 3 months prior to screening that, in the judgment of the investigator, would interfere with the absorption, distribution, metabolism, or excretion of the drug, or surgery within 4 weeks prior to the use of the investigational drug, or planned surgery during the research;
- Took any prescription, over-the-counter, and herbal medications within 2 weeks prior to screening, or were within 5 half-lives of the medication at the time of screening, and plan to take other experimental medications other than those in this study for the duration of the research;
- Other conditions unsuitable for the study confirmed by the investigator.
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 |
|---|---|---|
| JMKX000623JMKX000623, administered orally ; | Drug | JMKX000623/Metformin/ JMKX000623+Metformin |
| MetforminMetformin,administered orally | Drug | JMKX000623/Metformin/ JMKX000623+Metformin |
Primary outcome
Area Under the Dosing Time Curve During the Dosing Interval After Reaching Steady State（AUC0-tau）
Time frame: baseline through 4 days post-dose
Maximum observed After Reaching steady state concentration (Css,max)
Time frame: baseline through 4 days post-dose
1 secondary outcome
Adverse events (AEs)
Time frame: baseline through 4 days post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Xiaojie Wu, MD principal investigator
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JMKX000623 and Metformin in people with Healthy and Drug-Drug Interaction, run by Jemincare at 1 site in China.
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 5 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: finished, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Area Under the Dosing Time Curve During the Dosing Interval After Reaching Steady State（AUC0-tau） (time frame: baseline through 4 days post-dose). 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 25 Apr 2024.