Drug-Drug Interaction (DDI) Study for TQB3616

Phase I Clinical Trial Evaluating Drug Drug Interactions of TQB3616 Capsules

To evaluate the effect of itraconazole/rifampicin on the pharmacokinetics of TQB3616 capsules.

To assess the safety of a single dose of oral TQB3616 capsules and in combination with itraconazole/rifampicin.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: TQB3616 capsule + itraconazole; Drug: TQB3616 capsule + rifampicin

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Laichun Lu; Phone Number: 138 8393 3701; Email: lulaicq@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Beijing Tongren Hospital Affiliated to Capital Medical University
      • Contact: Laichun Lu, Doctor; Phone Number: 138 8393 3701; Email: lulaicq@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• At the time of signing the informed consent form, the age is 18~45 years old (including the cut-off value), both male and female;
• Females ≥ 45kg, males ≥ 50kg, body mass index (BMI) is 19~26 kg/m^2 (including the critical value), BMI = weight (kg)/height^2 (m^2);
• Those with normal vital signs, physical examination, clinical laboratory examination, imaging examination, 12-lead electrocardiogram, or abnormal but no clinical significance as judged by the investigator;
• Subject is able to comply with study procedures, voluntarily participate in this trial, and sign an informed consent form in writing.

Exclusion Criteria:

• Those who have suffered or are currently suffering from any clinically serious diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, genitourinary system, hematology, immunology, psychiatry and metabolic abnormalities or any other diseases that can interfere with the test results;
• Those who have systemic/local acute infection before taking the study drug;
• Those with a history of food or drug allergies, or allergies;
• Those who have dysphagia or suffer from any gastrointestinal diseases that affect drug absorption at the time of screening;
• Those who cannot accept intravenous indwelling needle puncture blood vessels to collect blood samples, or the subjects cannot tolerate venipuncture, or have a history of needle fainting or blood sickness;
• Regular drinkers within 6 months before the first dose, that is, those who drink more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirits with 40% alcohol or 150 mL of wine) or those who have a positive alcohol breath test at screening;
• History of major surgical operation (defined as difficult and complex intraoperative surgery, such as gastric and duodenal surgery, partial nephrectomy, radical resection of malignant tumor, etc.) within 3 months before the first dose, or have taken investigational drugs or participated in other drug clinical trials;
• Blood donation or massive blood loss (>400 mL) within 3 months before the first dose;
• Those who have used drugs within 3 months before the first dose, or those who have a positive drug screen, or those who have a history of drug abuse within five years before screening;
• Those who smoke more than 5 cigarettes per day within 3 months before the first dose or those who cannot stop using any tobacco products during the trial;
• Daily consumption of excessive tea, coffee, and/or caffeinated beverages (more than 8 cups, 1 cup=250 mL) within 30 days prior to the first dose;
• Use of any drug that inhibits or induces the hepatic metabolism of the drug within 30 days before the first dose (such as: CYP3A4 inducers carbamazepine, dexamethasone, rifampicin, phenytoin, phenobarbital, St. John's worn, etc.); CYP3A4 inhibitors itraconazole, ketoconazole, clarithromycin, telithromycin, lopinavir, ritonavir, etc.);
• Have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health products within 14 days before the first dose;
• Those who have taken a special diet (such as grapefruit) or other factors that affect the absorption, distribution, metabolism, and excretion of drugs within 7 days before the first dose;
• Ingestion of chocolate, any caffeine-containing, or xanthine-rich food or drink 48 hours prior to the first dose;
• Those who have special dietary requirements and cannot comply with the unified diet;
• Pregnant or lactating women, as well as subjects and their spouses who have childbearing, or sperm donation, or egg donation plans within 3 months from signing the informed consent form to the last dose, or who cannot guarantee the use of effective contraception during this period (taking one or more non-drug contraceptive measures during the trial);
• Subjects who are judged by the investigator to be unsuitable to participate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Inhibitor group; Oral TQB3616 capsules 60 mg after a single meal on days 1 and 13; On days 10 to 21, itraconazole capsules 200mg were taken orally once a day for 12 days after meals.	Drug: TQB3616 capsule + itraconazole; C2/4/6 inhibitors + CYP3A metabolic enzyme inhibitors
Experimental: Inducer group; 180mg of TQB3616 capsules orally after a single meal on days 1 and 17; Oral administration of rifampicin capsules 600mg from day 10 to day 25 on the peritoneum once a day for 16 consecutive days, of which rifampicin capsules 600mg and TQB3616 capsules 180mg were taken at the same time after meals on the 17th day.	Drug: TQB3616 capsule + rifampicin; C2/4/6 inhibitors + Non-specific cytochrome P450 enzyme inducer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak concentration (Cmax)	Maximum plasma drug concentration	Before administration, 1,2,4,6,8,12,24,48,72,120,168,216 hours after administration
Area under drug time curve (AUC0-t)	Area under the plasma concentration time curve from time 0 to last time of quantifiable concentration.	Before administration, 1,2,4,6,8,12,24,48,72,120,168,216 hours after administration
Area under drug time curve (AUC0-∞)	Area under the plasma concentration-time curve from time 0 extrapolated to infinite time.	Before administration, 1,2,4,6,8,12,24,48,72,120,168,216 hours after administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse event rate	Incidence and severity of adverse events and serious adverse events, and abnormal laboratory examination indicators.	From before the first administration to 26 days after the administration

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: October 28, 2024
• First Submitted That Met QC Criteria: October 28, 2024
• First Posted (Actual): October 29, 2024

Study Record Updates

• Last Update Posted (Actual): October 29, 2024
• Last Update Submitted That Met QC Criteria: October 28, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Bacterial Agents; Anti-Infective Agents; Antifungal Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Enzyme Inhibitors; Nucleic Acid Synthesis Inhibitors; Steroid Synthesis Inhibitors; Hormone Antagonists; Cytochrome P-450 Enzyme Inhibitors; Antibiotics, Antitubercular; Antitubercular Agents; Cytochrome P-450 CYP3A Inhibitors; Leprostatic Agents; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP2C8 Inducers; Cytochrome P-450 CYP2C19 Inducers; Cytochrome P-450 CYP2C9 Inducers; Cytochrome P-450 CYP3A Inducers; 14-alpha Demethylase Inhibitors; Rifampin; Itraconazole
• Other Study ID Numbers: TQB3616-I-05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No