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

NCT06348290 | Not Yet Recruiting Phase 1

• 1 other identifier: JY-JM1899-105
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Solid Tumor, Adult

Outcome Measures

Primary Outcomes (3)

• maximum concentrations (Cmax ) for plasma

  approximately 3 days after first dose

• area under the curve from time 0 to infinity(AUC0-inf) for plasma

  approximately 3 days after first dose

• area under the curve from time 0 to the last time point (AUC0-t) for plasma

  approximately 3 days after first dose

Study Arms (3)

JMKX001899+Itraconazole

EXPERIMENTAL

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

Drug: JMKX001899; Drug: Itraconazole

JMKX001899+Rifampin

EXPERIMENTAL

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.

Drug: JMKX001899; Drug: Rifampin

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

EXPERIMENTAL

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.

Drug: JMKX001899; Drug: Midazolam; Drug: dextromethorphan; Drug: Rosuvastatin; Drug: digoxin

Interventions

JMKX001899 DRUG

Oral

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

Itraconazole DRUG

Oral

JMKX001899+Itraconazole

Midazolam DRUG

Oral

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

Rifampin DRUG

Oral

JMKX001899+Rifampin

dextromethorphan DRUG

Oral

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

Rosuvastatin DRUG

Oral

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

digoxin DRUG

Oral

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• subjects aged 18 to 45 years (including both ends) at the time of signing informed consent.
• 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).

You may not qualify if:

• hepatitis B surface antigen HBsAg positive, hepatitis C virus antibody positive, positive AIDS antigen/antibody or Treponema pallidum antibody.
• 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.
• have taken any products containing caffeine, alcohol, grapefruit, and xanthine-rich within 24 hours before taking study medication.

Sponsors & Collaborators

• Jemincare: lead

MeSH Terms

Interventions

Itraconazole; Midazolam; Rifampin; Dextromethorphan; Rosuvastatin Calcium; Digoxin

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Glycosides; Carbohydrates

Central Study Contacts

JING XU

CONTACT

+86-021-52887926; xujing2@jemincare.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: April 4, 2024
• Study Start: April 1, 2024
• Primary Completion: May 31, 2024
• Study Completion: September 15, 2024
• Last Updated: April 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share