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Clinical Trials in China / NCT07768111
Starting soon Phase 1

Clinical Study on Drug Interactions of Flonoltinib Maleate Tablets

NCT07768111 · tracked via the Priya Life Science China tracker
Sponsor
Chengdu Zenitar Biomedical Technology Co., Ltd
Phase
Phase 1
Started
2026-10-30
Last updated
2026-08-19

Condition(s) studied

Drug Interaction Research

Investigational drug(s) / intervention(s)

75mg Flonoltinib →100mg Flonoltinib →

75mg Flonoltinib: Day 1 and Day 12 : 75mg Flonoltinib on an empty stomach in the morning

100mg Flonoltinib: Day 1 and Day 19 : 100mg Flonoltinib on an empty stomach in the morning

Study summary

This study is a single center, open label, fixed sequence drug interaction study to evaluate the effects of CYP3A4 inhibitor itraconazole and CYP3A4 inducer rifampicin on the pharmacokinetic characteristics of a single oral dose of flonotinib maleate tablets.

This trial includes screening period, baseline period, medication observation period, and follow-up period, totaling approximately 3 months.

Eligibility

Sex
ALL
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. Chinese healthy adult , aged 18-45 years old 2. During the screening period, participants male weight \>=50.0 kg, female weight \>=45.0 kg and having a body mass index (BMI) between 19.0 and 26.0 kg/m\^2 3. Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent form, and be able to complete the entire trial process according to the trial requirements. Exclusion Criteria: 1. Screening period electrocardiogram examination: Fridericia formula (QTcF=QT/(RR \^ 0.33)) corrected QT interval (QTcF)\>450 milliseconds 2. HBsAg,HBeAg, hepatitis C antibody, treponema pallidum antibody or HIV Ag/Ab combined test 3. Individuals with a history of drug abuse or drug use, or positive urine drug abuse screening results 4. Individuals who have consumed any food or beverage containing alcohol, grapefruit juice/grapefruit juice, or methylxanthine (such as coffee, tea, cola, chocolate, functional drinks) within 48 hours prior to check-in 5. Individuals with a history of needle or blood dizziness, difficulty in blood collection, or intolerance to venipuncture blood collection

Primary outcome measure(s)

  • Cmax — Until 144hours
  • Tmax — Until 144hours
  • AUC0-t — Until 144hours
  • t1/2 — Until 144hours

Trial sites (1)

FacilityCityRegionStatus
The Second Affiliated Hospital of Anhui Medical University Hefei Anhui

More Chengdu Zenitar Biomedical Technology Co., Ltd trials in China

A Clinical Trial of Flonoltinib Maleate Tablets in the Treatment of JAK Inhibitor Refractory/Relapsed/Intolerant Patients With Intermediate to High Risk Myelofibrosis Recruiting
Purinostat Mesylate Combined With Pomalidomide Capsules and Low-dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma Recruiting
A Clinical Trial of Flonoltinib Maleate for Intermediate or High-Risk Myelofibrosis Recruiting
A Phase II Clinical Trial of Flonoltinib Maleate Tablet in Intermediate-High Risk Myelofibrosis Active, not recruiting
Mass Balance Study of [¹⁴C]Purinostat Mesylate for Injection in Healthy Participants Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07768111 on ClinicalTrials.gov ↗ ← All trials in China