A Phase I Study to Evaluate Drug-Drug Interaction of TQB3909 Tablets
Overview
- Phase
- Phase 1
- Intervention
- TQB3909 tablets
- Conditions
- Advanced Malignant Neoplasm
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Time to Reach Maximum Observed Plasma Concentration (Tmax)
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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/m
- •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；
Arms & Interventions
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.
Intervention: TQB3909 tablets
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.
Intervention: Itraconazole capsule
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.
Intervention: TQB3909 tablets
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.
Intervention: Rifampicin capsule
Outcomes
Primary Outcomes
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame: 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.
Time to reach maximum (peak) plasma concentration following drug administration.
Maximum Plasma Concentration (Cmax)
Time Frame: 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.
The maximum observed plasma concentration of TQB3909
Elimination half-life (t1/2)
Time Frame: 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.
The time required for half of the drug to be eliminated from the plasma.
Secondary Outcomes
- Incidence of adverse events (AEs)(Up to 12 days.)