A Study to Evaluate Drug-Drug Interaction of TQB3909 Tablets

Advanced Malignant Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06165822
• Other study ID #: TQB3909-I-02
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: December 2023
• Est. completion date: March 2024

Study information

• Verified date: November 2023
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Fei Hua, MD, PhD
• Phone: 0519-68870002
• Email: czyyphase1[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Malignant Neoplasm
• Neoplasms

Intervention

Drug:
• TQB3909 tablets
TQB3909 100mg/tablet.
• Itraconazole capsule
Itraconazole capsule is a strong inhibitor of CYP3A4.
• Rifampicin capsule
Rifampicin capsule is a strong inducer of CYP3A4.

Locations

Country	Name	City	State
China	The First People's Hospital of Changzhou	Changzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.