Study to Evaluate the Drug-drug Interaction of JMKX001899 in Healthy Subjects

Jemincare

Status and phase: Not yet enrolling; Phase 1

Conditions: Solid Tumor, Adult

Treatments: Drug: Midazolam; Drug: dextromethorphan; Drug: Rosuvastatin; Drug: JMKX001899; Drug: digoxin; Drug: Rifampin; Drug: Itraconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT06348290

JY-JM1899-105

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 3 patient groups

JMKX001899+Itraconazole

Experimental group

Description:

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

Treatment:

Drug: Itraconazole

Drug: JMKX001899

JMKX001899+Rifampin

Experimental group

Description:

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.

Treatment:

Drug: Rifampin

Drug: JMKX001899

JMKX001899+Cocktail substrate (Midazolam, dextromethorphan, Rosuvastatin and digoxin)

Experimental group

Description:

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.

Treatment:

Drug: digoxin

Drug: Midazolam

Drug: JMKX001899

Drug: dextromethorphan

Drug: Rosuvastatin