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NCT06348290 Clinical Trial

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

Solid Tumor, Adult Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06348290
Other study ID # JY-JM1899-105
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date April 1, 2024
Est. completion date September 15, 2024

Study information
Verified date March 2024
Source Jemincare
Contact JING XU
Phone +86-021-52887926
Email xujing2@jemincare.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 72
Est. completion date September 15, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• JMKX001899
Oral
• Itraconazole
Oral
• Midazolam
Oral
• Rifampin
Oral
• dextromethorphan
Oral
• Rosuvastatin
Oral
• digoxin
Oral

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Jemincare

Outcome
Type Measure Description Time frame Safety issue
Primary maximum concentrations (Cmax ) for plasma approximately 3 days after first dose
Primary area under the curve from time 0 to infinity(AUC0-inf) for plasma approximately 3 days after first dose
Primary area under the curve from time 0 to the last time point (AUC0-t) for plasma approximately 3 days after first dose
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