Solid Tumor, AdultPhase 1NCT06348290
Study to Evaluate the Drug-drug Interaction of JMKX001899 in Healthy Subjects
A Phase 1 study testing JMKX001899, Itraconazole and Midazolam in people with Solid Tumor, Adult, run by Jemincare.
Trial summary
This is an open-label, non-randomized, clinical study to evaluate the drug interaction between itraconazole, rifampin or Cocktail and JMKX001899 in healthy subjects. A total of three cohorts of 72 healthy subjects were planned to be enrolled in each cohort. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- JMKX001899, Itraconazole and Midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 15 Sep 2024
- 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
- voluntarily sign the informed consent, fully understand the content of the trial, and be able to complete the study according to the requirements of the trial protocol.
- subjects aged 18 to 45 years (including both ends) at the time of signing informed consent.
- male body weight is not less than 50 kg, female body weight is not less than 50 kg, and body mass index (BMI) is within the range of 19 ~ 27 kg/m2 (including cut-off value).
Who cannot join
- hepatitis B surface antigen HBsAg positive, hepatitis C virus antibody positive, positive AIDS antigen/antibody or Treponema pallidum antibody.
- Patients with a history of clinically significant diseases including, but not limited to, gastrointestinal, renal, liver, neurological, hematological, endocrine, neoplastic, pulmonary, immune, psychiatric, or cardiovascular and cerebrovascular diseases, epilepsy, bipolar disorder/mania, intraocular hypertension, or acute angle-closure glaucoma.
- have taken any products containing caffeine, alcohol, grapefruit, and xanthine-rich within 24 hours before taking study medication.
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 JMKX001899 Tablets in Healthy Subjects
This is an open-label, non-randomized, clinical study to evaluate the drug interaction between itraconazole, rifampin or Cocktail and JMKX001899 in healthy subjects. A total of three cohorts of 72 healthy subjects were planned to be enrolled in each cohort.
- Conditions
- Solid Tumor, Adult
- Being tested
- JMKX001899, Itraconazole, Midazolam, Rifampin, dextromethorphan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JMKX001899Drug
Oral
ItraconazoleDrug
Oral
MidazolamDrug
Oral
RifampinDrug
Oral
dextromethorphanDrug
Oral
RosuvastatinDrug
Oral
digoxinDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| JMKX001899+Itraconazole | Experimental | Enrolled subjects were treated with JMKX001899 on Day 1. Itraconazole was administered orally once daily after a standardized meal from Day 4 to Day 6. JMKX001899 and itraconazole were administered simultaneously after a standardized meal on Day 7. On Day 8 to Day 9, itraconazole was orally administered once after a standard meal Receives: Drug: JMKX001899; Drug: Itraconazole |
| JMKX001899+Rifampin | Experimental | Enrolled subjects were treated with JMKX001899 after high fat meal on Day 1 and an empty stomach on Day 4. Rifampin was administered orally once daily on an empty stomac from Day 7 to Day 15, Day 17and Day 18. JMKX001899 and Rigampin were administered simultaneously on an empty stomach on Day 16. Receives: Drug: JMKX001899; Drug: Rifampin |
| JMKX001899+Cocktail substrate (Midazolam, dextromethorphan, Rosuvastatin and digoxin) | Experimental | Enrolled subjects were treated with Cocktail substrate (Midazolam, dextromethorphan, Rosuvastatin and digoxin) on an empty stomach on Day 1. JMKX001899 was administered orally once daily after a standardized meal from Day 9 to Day 20 and Day 22. Cocktail and JMKX001899 were administered simultaneously on an empty stomach on Day 8 and Day 21. Receives: Drug: JMKX001899; Drug: Midazolam; Drug: dextromethorphan; Drug: Rosuvastatin; Drug: digoxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum concentrations (Cmax ) for plasma
Measured: approximately 3 days after first dose
area under the curve from time 0 to infinity(AUC0-inf) for plasma
Measured: approximately 3 days after first dose
area under the curve from time 0 to the last time point (AUC0-t) for plasma
Measured: approximately 3 days after first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start1 Apr 2024 (estimated)
- Primary completion31 May 2024 (estimated)
- Study completion15 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies 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
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jemincare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348290
- Sponsor's protocol ID
- JY-JM1899-105
- Status last verified
- Mar 2024
- First submitted
- 21 Mar 2024
- Last updated
- 4 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 4 Apr 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 JMKX001899 Tablets in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06348290
- Acronym / sponsor ID
- JY-JM1899-105
- Conditions
- Solid Tumor, Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- JemincareIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 15 Sep 2024 (estimated)
- First posted
- 4 Apr 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.
This is an open-label, non-randomized, clinical study to evaluate the drug interaction between itraconazole, rifampin or Cocktail and JMKX001899 in healthy subjects. A total of three cohorts of 72 healthy subjects were planned to be enrolled in each cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| JMKX001899+Itraconazole | Experimental | Drug: JMKX001899, Drug: ItraconazoleEnrolled subjects were treated with JMKX001899 on Day 1. Itraconazole was administered orally once daily after a standardized meal from Day 4 to Day 6. JMKX001899 and itraconazole were administered simultaneously after a standardized meal on Day 7. On Day 8 to Day 9, itraconazole was orally administered once after a standard meal |
| JMKX001899+Rifampin | Experimental | Drug: JMKX001899, Drug: RifampinEnrolled subjects were treated with JMKX001899 after high fat meal on Day 1 and an empty stomach on Day 4. Rifampin was administered orally once daily on an empty stomac from Day 7 to Day 15, Day 17and Day 18. JMKX001899 and Rigampin were administered simultaneously on an empty stomach on Day 16. |
| JMKX001899+Cocktail substrate (Midazolam, dextromethorphan, Rosuvastatin and digoxin) | Experimental | Drug: JMKX001899, Drug: Midazolam, Drug: dextromethorphan, Drug: Rosuvastatin, Drug: digoxinEnrolled subjects were treated with Cocktail substrate (Midazolam, dextromethorphan, Rosuvastatin and digoxin) on an empty stomach on Day 1. JMKX001899 was administered orally once daily after a standardized meal from Day 9 to Day 20 and Day 22. Cocktail and JMKX001899 were administered simultaneously on an empty stomach on Day 8 and Day 21. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- voluntarily sign the informed consent, fully understand the content of the trial, and be able to complete the study according to the requirements of the trial protocol.
- subjects aged 18 to 45 years (including both ends) at the time of signing informed consent.
- male body weight is not less than 50 kg, female body weight is not less than 50 kg, and body mass index (BMI) is within the range of 19 ~ 27 kg/m2 (including cut-off value).
Key exclusion criteria (3 listed)
- hepatitis B surface antigen HBsAg positive, hepatitis C virus antibody positive, positive AIDS antigen/antibody or Treponema pallidum antibody.
- Patients with a history of clinically significant diseases including, but not limited to, gastrointestinal, renal, liver, neurological, hematological, endocrine, neoplastic, pulmonary, immune, psychiatric, or cardiovascular and cerebrovascular diseases, epilepsy, bipolar disorder/mania, intraocular hypertension, or acute angle-closure glaucoma.
- have taken any products containing caffeine, alcohol, grapefruit, and xanthine-rich within 24 hours before taking study medication.
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 |
|---|---|---|
| JMKX001899Oral | Drug | JMKX001899+Cocktail substrate (Midazolam, dextromethorphan, Rosuvastatin and digoxin), JMKX001899+Itraconazole, JMKX001899+Rifampin |
| ItraconazoleOral | Drug | JMKX001899+Itraconazole |
| MidazolamOral | Drug | JMKX001899+Cocktail substrate (Midazolam, dextromethorphan, Rosuvastatin and digoxin) |
| RifampinOral | Drug | JMKX001899+Rifampin |
| dextromethorphanOral | Drug | JMKX001899+Cocktail substrate (Midazolam, dextromethorphan, Rosuvastatin and digoxin) |
| RosuvastatinOral | Drug | JMKX001899+Cocktail substrate (Midazolam, dextromethorphan, Rosuvastatin and digoxin) |
| digoxinOral | Drug | JMKX001899+Cocktail substrate (Midazolam, dextromethorphan, Rosuvastatin and digoxin) |
Primary outcome
maximum concentrations (Cmax ) for plasma
Time frame: approximately 3 days after first dose
area under the curve from time 0 to infinity(AUC0-inf) for plasma
Time frame: approximately 3 days after first dose
area under the curve from time 0 to the last time point (AUC0-t) for plasma
Time frame: approximately 3 days after first dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Solid Tumor, Adult
Recruiting
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
Solid Tumor, Adult, Solid Tumor, Childhood
Active, not recruitingPhase 1
Advanced or Recurrent Solid Tumors Treated With SHetA2
Solid Tumor, Adult
RecruitingObservational study
NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors
Very Rare Tumors, Very Rare Cancers
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JMKX001899, Itraconazole and Midazolam in people with Solid Tumor, Adult, 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 3 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 4 Apr 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 JING XU (+86-021-52887926, xujing2@jemincare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximum concentrations (Cmax ) for plasma (time frame: approximately 3 days after first dose). The study lists 3 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 4 Apr 2024.