Study to Evaluate the Drug-drug Interaction of JMKX001899 in Healthy Subjects
NCT ID: NCT06348290
Last Updated: 2024-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
72 participants
INTERVENTIONAL
2024-04-01
2024-09-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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JMKX001899+Itraconazole
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
JMKX001899
Oral
Itraconazole
Oral
JMKX001899+Rifampin
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.
JMKX001899
Oral
Rifampin
Oral
JMKX001899+Cocktail substrate (Midazolam, dextromethorphan, Rosuvastatin and digoxin)
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.
JMKX001899
Oral
Midazolam
Oral
dextromethorphan
Oral
Rosuvastatin
Oral
digoxin
Oral
Interventions
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JMKX001899
Oral
Itraconazole
Oral
Midazolam
Oral
Rifampin
Oral
dextromethorphan
Oral
Rosuvastatin
Oral
digoxin
Oral
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
45 Years
ALL
Yes
Sponsors
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Jemincare
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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JY-JM1899-105
Identifier Type: -
Identifier Source: org_study_id
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