Drug-Drug Interaction (DDI) Study for TQB3616

Official title

Phase I Clinical Trial Evaluating Drug Drug Interactions of TQB3616 Capsules

Overview

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.

Interventions

• Drug TQB3616 capsule + itraconazole
  C2/4/6 inhibitors + CYP3A metabolic enzyme inhibitors
• Drug TQB3616 capsule + rifampicin
  C2/4/6 inhibitors + Non-specific cytochrome P450 enzyme inducer

Primary outcome measures

• Peak concentration (Cmax) [Time frame: Before administration, 1,2,4,6,8,12,24,48,72,120,168,216 hours after administration]
• Area under drug time curve (AUC0-t) [Time frame: Before administration, 1,2,4,6,8,12,24,48,72,120,168,216 hours after administration]
• Area under drug time curve (AUC0-∞) [Time frame: Before administration, 1,2,4,6,8,12,24,48,72,120,168,216 hours after administration]

Secondary outcome measures (1)

• Adverse event rate [Time frame: From before the first administration to 26 days after the administration]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Beijing Tongren Hospital Affiliated to Capital Medical University — Beijing

Identifiers

NCT: NCT06662773 · TQB3616-I-05

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗