A Study to Evaluate Drug-Drug Interaction of TQB3909 Tablets

A Phase I Study to Evaluate Drug-Drug Interaction of TQB3909 Tablets

This is a single-center, open, single-dose, self-controlled phase I clinical trial to evaluate the effects of Itraconazole Capsules/Rifampicin Capsules on pharmacokinetics of TQB3909 tablets in vivo, and the safety of TQB3909 tablets and combined with Itraconazole Capsules/Rifampicin Capsules after single oral dose.

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Malignant Neoplasm
• Intervention / Treatment: Drug: TQB3909 tablets; Drug: Itraconazole capsule; Drug: Rifampicin capsule

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

Contacts and Locations

• Study Contact: Name: Fei Hua, MD, PhD; Phone Number: 0519-68870002; Email: czyyphase1@163.com
• Study Contact Backup: Name: Weiying Gu, MD, PhD; Phone Number: 0519-68871092; Email: guweiying2001@163.com

Study Locations

• China
  • Jiangsu
    • Changzhou, Jiangsu, China, 213004
      • The First People's Hospital Of Changzhou
      • Contact: Fei Hua, MD, PhD; Phone Number: 0519-68870002; Email: czyyphase1@163.com
      • Contact: Weiying Gu, MD, PhD; Phone Number: 0519-68871092; Email: guweiying2001@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, males or females of between 18 and 45 years of age;
• Female weight ≥45 kg, male weight ≥50 kg, with a body mass index (BMI) between 19 and 26 kg/m2.
• Subjects in good health, as determined by a medical history, vital signs, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations;
• Subjects can comply with the study procedures, voluntarily participate in the study, and sign the informed consent in person.

Exclusion Criteria:

• Subjects: pre-existing or existing circulatory system, endocrine system, nervous system, digestive system, respiratory system, genitourinary system, hematology, immunology, psychiatry and metabolic disorders mental diseases or abnormalities, or related chronic or acute diseases, which were not appropriate to participate in the trial as assessed by the investigators ;
• Subjects with systemic/local acute infection presented before study drug administration;
• Subjects who have a history of specific allergies, or allergies;
• Subjects who have difficulty in swallowing or have any gastrointestinal disorder that affects drug absorption at the time of screening；
• Subjects who cannot receive venous indwelling needle for blood sample collection；
• Subjects who cannot tolerate venous puncture or have a history of needle or blood sickness;
• Subjects who drank regularly within the 6 months prior to the first dosing, such as those who drank more than 14 units of alcohol per week or who had a positive alcohol breath test at the time of screening；
• Subjects who had a history of major surgery, had taken the study drug, or had participated in other drug clinical trials within 3 months prior to the first dosing；
• Subjects who donated blood or lost significant amounts of blood within 3 months prior to the first dosing；
• Subjects who had used drugs within 3 months prior to the first dosing, or tested positive for drugs, or had a history of drug abuse within 5 years prior to screening；
• Subjects who smoked more than 5 cigarettes per day within the 3 months prior to the first dosing or who could not stop using any tobacco products during the trial；
• Subjects who consumed excessive amounts of tea, coffee, and/or caffeinated beverages daily within the 30 days prior to the first dosing；
• Subjects who have used any drug that inhibits or induces liver metabolism of the drug within the 30 days prior to the first dosing；
• Subjects who have taken any prescription, over-the-counter, herbal, or health product within the 14 days prior to the first dosing；
• Subjects who have taken a special diet or other factors affecting drug absorption, distribution, metabolism, or excretion within 7 days prior to the first dosing；
• Subjects who ingested chocolate, any caffeinated, or xanthine-rich food or drink within 48 hours before the first dosing；
• Subjects who have special dietary requirements and cannot follow a uniform diet；
• Female subjects of child-bearing potential；
• Subjects judged by the investigators 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: Itraconazole drug-durg interaction (DDI); Itraconazole capsules, 0.2g once daily from Day 3 to Day 10 TQB3909 tablets, single oral dose on Day 1 and Day 8.	Drug: TQB3909 tablets; TQB3909 100mg/tablet.; Drug: Itraconazole capsule; Itraconazole capsule is a strong inhibitor of CYP3A4.
Experimental: Rifampicin DDI; Rifampicin capsule, 0.6g once daily from Day 3 to Day 11. TQB3909 tablets, single oral dose on Day 1 and Day 10.	Drug: TQB3909 tablets; TQB3909 100mg/tablet.; Drug: Rifampicin capsule; Rifampicin capsule is a strong inducer of CYP3A4.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Reach Maximum Observed Plasma Concentration (Tmax)	Time to reach maximum (peak) plasma concentration following drug administration.	Inhibitor group: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 14, 24, 48, 72 hours (only on Day 8) after dose on Day 1 and Day 8. Inducer group: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 14, 24, 48 hours after dose on Day 1 and Day 10.
Maximum Plasma Concentration (Cmax)	The maximum observed plasma concentration of TQB3909	Inhibitor group: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 14, 24, 48, 72 hours (only on Day 8) after dose on Day 1 and Day 8. Inducer group: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 14, 24, 48 hours after dose on Day 1 and Day 10.
Elimination half-life (t1/2)	The time required for half of the drug to be eliminated from the plasma.	Inhibitor group: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 14, 24, 48, 72 hours (only on Day 8) after dose on Day 1 and Day 8. Inducer group: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 14, 24, 48 hours after dose on Day 1 and Day 10.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events (AEs)	Incidence of adverse events (AEs) based on the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0	Up to 12 days.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: November 30, 2023
• First Submitted That Met QC Criteria: December 4, 2023
• First Posted (Estimated): December 12, 2023

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Drug drug interaction
• Additional Relevant MeSH Terms: Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Leprostatic Agents; Hormone Antagonists; Cytochrome P-450 Enzyme Inducers; Antifungal Agents; Steroid Synthesis Inhibitors; Cytochrome P-450 CYP3A Inducers; Antitubercular Agents; 14-alpha Demethylase Inhibitors; Antibiotics, Antitubercular; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 CYP2C8 Inducers; Cytochrome P-450 CYP2C19 Inducers; Cytochrome P-450 CYP2C9 Inducers; Rifampin; Itraconazole
• Other Study ID Numbers: TQB3909-I-02

Drug and device information, study documents

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