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
• Status: Not yet recruiting
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Solid Tumor, Adult

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