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.

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.1 site in 1 country40 target enrollmentNovember 2023

ConditionsBiliary Carcinoma

InterventionsTQB3454 tablets

DrugsTQB3454 tablets

Overview

Phase: Phase 1
Intervention: TQB3454 tablets
Conditions: Biliary Carcinoma
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Enrollment: 40
Locations: 1
Primary Endpoint: Peak concentration (Cmax)
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2023

End Date

December 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Responsible Party

Sponsor

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;

Arms & Interventions

TQB3454 tablets under fast condition

TQB3454 tablets 600mg, take one dose orally under fast condition.

Intervention: TQB3454 tablets

TQB3454 tablets under fed condition

TQB3454 tablets 600mg, take one dose orally under fed condition.

Intervention: TQB3454 tablets