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Trial Title:
Study to Evaluate the Drug-drug Interaction of JMKX001899 in Healthy Subjects
NCT ID:
NCT06348290
Condition:
Solid Tumor, Adult
Conditions: Official terms:
Itraconazole
Rifampin
Digoxin
Midazolam
Levomethorphan
Dextromethorphan
Rosuvastatin Calcium
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
JMKX001899
Description:
Oral
Arm group label:
JMKX001899+Cocktail substrate (Midazolam, dextromethorphan, Rosuvastatin and digoxin)
Arm group label:
JMKX001899+Itraconazole
Arm group label:
JMKX001899+Rifampin
Intervention type:
Drug
Intervention name:
Itraconazole
Description:
Oral
Arm group label:
JMKX001899+Itraconazole
Intervention type:
Drug
Intervention name:
Midazolam
Description:
Oral
Arm group label:
JMKX001899+Cocktail substrate (Midazolam, dextromethorphan, Rosuvastatin and digoxin)
Intervention type:
Drug
Intervention name:
Rifampin
Description:
Oral
Arm group label:
JMKX001899+Rifampin
Intervention type:
Drug
Intervention name:
dextromethorphan
Description:
Oral
Arm group label:
JMKX001899+Cocktail substrate (Midazolam, dextromethorphan, Rosuvastatin and digoxin)
Intervention type:
Drug
Intervention name:
Rosuvastatin
Description:
Oral
Arm group label:
JMKX001899+Cocktail substrate (Midazolam, dextromethorphan, Rosuvastatin and digoxin)
Intervention type:
Drug
Intervention name:
digoxin
Description:
Oral
Arm group label:
JMKX001899+Cocktail substrate (Midazolam, dextromethorphan, Rosuvastatin and digoxin)
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 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.
2. subjects aged 18 to 45 years (including both ends) at the time of signing informed
consent.
3. 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).
Exclusion Criteria:
1. hepatitis B surface antigen HBsAg positive, hepatitis C virus antibody positive,
positive AIDS antigen/antibody or Treponema pallidum antibody.
2. 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.
3. have taken any products containing caffeine, alcohol, grapefruit, and xanthine-rich
within 24 hours before taking study medication.
Gender:
All
Minimum age:
18 Years
Maximum age:
45 Years
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
April 1, 2024
Completion date:
September 15, 2024
Lead sponsor:
Agency:
Jemincare
Agency class:
Industry
Source:
Jemincare
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06348290
