Clinical trial NCT06139367: A Clinical Trial of TQB3454 Tablets in Healthy Adult Subjects
Official title: A Randomized, Open, Parallel, Single Center Phase I Clinical Trial to Evaluate the Effect of Food on the Pharmacokinetics of TQB3454 Tablets in Healthy Adult Subjects.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Biliary Carcinoma
Keywords: Food effect
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-11-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, open, parallel, single center phase I clinical trial to evaluate the impact of food on the pharmacokinetics of TQB3454 tablets in healthy adult subjects. The aim is to evaluate the impact of food on the pharmacokinetics as well as the safety after single dose of TQB3454 tablets taken orally by Chinese healthy adult subjects, with pharmacokinetic indicators as the primary endpoint.


Eligibility criteria: Inclusion Criteria:

* Sign an informed consent form before the experiment and fully understand the content, process, and potential adverse reactions of the study;
* Able to complete the study according to the requirements of the protocol;
* Subjects aged 18-65 (inclusive);
* Body mass index (BMI) ≥ 18 and ≤ 28 kg/m\^2, and male's weight ≥ 50 kg and female's weight ≥ 45 kg;
* Health status: No mental abnormalities, no history of severe neurological, respiratory, digestive, urinary, endocrine, and metabolic abnormalities;
* The subjects have no pregnancy plan, voluntarily take effective contraceptive measures, and no plans to donate sperm or eggs, from the date of signing the inform consent (14 days before signing the inform consent for female subjects) to at least 6 months after the last administration.

Exclusion Criteria:

* Subjects with allergic constitution or a history of allergies to two or more foods or drugs;
* Subjects who have experienced arterial/venous thrombosis events within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis, and pulmonary embolism;
* Suffering from ≥ Level 2 myocardial ischemia or infarction, arrhythmia (including QTc ≥ 450 ms for male, QTc ≥ 470 ms for female), and ≥ Level 2 congestive heart failure (New York Heart Association (NYHA) classification);
* Those with multiple factors that affect oral medication (such as inability to swallow, gastrointestinal diseases);
* Have taken any prescription, over-the-counter, vitamin product, or herbal medicine within one month before the first administration;
* Take CYP3A4 inhibitors or inducers within one month before the first administration or before the study medication;
* Those who have taken a special diet (including grapefruit, etc.) or engaged in vigorous exercise within 14 days before the first administration or have other factors that affect drug absorption, distribution, metabolism, excretion, etc.;
* Abnormal and clinically significant physical examination, vital signs, electrocardiogram, and laboratory tests during the screening period;
* Donated blood or experienced significant blood loss (\>450 mL) within 3 months prior to taking the study drug;
* Participated in any clinical trial and took any investigational drug within 3 months prior to taking the study drug;
* Smoke at least 5 cigarettes per day within 3 months prior to the study;
* Positive alcohol breath test or history of alcoholism within 2 weeks prior to screening (drinking 14 units of alcohol per week: 1 unit=360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine);
* Drug screening positive or those who have used drugs in the past 3 months prior to the study;
* Inability to tolerate venous puncture for blood collection or poor vascular condition;
* The subject is unable to complete the experiment due to personal reasons;
* Other conditions that it is considered not suitable for enrollment assessed by the investigators.

Primary outcomes:
measure: Peak concentration (Cmax)
timeFrame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose.
measure: Area under the time-concentration curve from 0 to t hours (AUC0-t)
timeFrame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose.
measure: Area under the time-concentration curve from 0 to infinity (AUC0-∞)
timeFrame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose.
measure: Time to peak (Tmax)
timeFrame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose.
measure: Elimination half-life (t1/2)
timeFrame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose.
measure: Apparent volume of distribution (Vd/F)
timeFrame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose.
measure: Apparent clearance (CL/F)
timeFrame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose.
measure: Elimination rate constant (λz)
timeFrame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose.
measure: Lag time (tlag)
timeFrame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose.
measure: Percentage of residual area (AUC% Extrap)
timeFrame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose.
Secondary outcomes:
measure: Adverse event rate
timeFrame: Before the first administration to 360 hours after the last administration.
measure: Adverse event severity
timeFrame: Before the first administration to 360 hours after the last administration.
Other outcomes:
Locations:
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
Study officials:
References: