Status:
COMPLETED
Clinical Trial for Effect of TQB3616 Capsule on Pharmacokinetics in Healthy Adult Subjects
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Recurrent/Metastatic Breast Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
TQB3616 capsule is a small molecule oral drug developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., which inhibits cyclin-dependent kinases 4 and 6 (CDK4/6). Its main mechanism of action is t...
Eligibility Criteria
Inclusion
- 1 Sign the informed consent form before the trial and fully understand the content, process and possible adverse reactions of the trial;
- 2 Be able to complete the study according to the requirements of the study protocol;
- 3 Subjects aged 18 to 65 years (including 18 and 65 years);
- 4 Body mass index (BMI) ≥ 18 and ≤ 28 kg/m2, and male body weight ≥ 50 kg Female body weight ≥ 45 kg;
- 5 Health condition: no mental disorders, no history of cardiovascular system, nervous system, respiratory system, digestive system, urinary system, endocrine system and metabolic abnormalities;
- 6 Subjets had no plans to become pregnant and voluntarily took effective contraceptive measures from 2 weeks before dosing to at least 6 months after the last dose of study drug.
Exclusion
- 1 Patients with a history of neuropsychiatric, respiratory, cardiovascular, gastrointestinal, hemolymphatic, hepatic or renal insufficiency, endocrine, musculoskeletal system disease or other diseases, which may affect drug metabolism or safety as judged by the investigator;
- 2 Allergic constitution or previous history of two or more kinds of food or drug allergy;
- 3 Hyperactive/venous thrombotic events within 6 months, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis and pulmonary embolism;
- 4 Patients with multiple factors affecting oral drugs (such as inability to swallow, gastrointestinal diseases);
- 5 Taking any prescription drugs, over-the-counter drugs, vitamin products or herbal medicines within 1 month before taking the study drug;
- 6 Administration of CYP3A4 inhibitors or inducers within 1 month before screening or before study drug;
- 7 Taking special diet (including grapefruit, etc.) or strenuous exercise, or other factors affecting drug absorption, distribution, metabolism, excretion, etc. within 14 days before screening;
- 8 Abnormal and clinically significant laboratory findings during the screening period;
- 9 Blood donation or significant blood loss (\> 450 mL) within 3 months prior to administration of study drug;
- 10 Participated in any drug clinical trial within 3 months before taking the study drug;
- 11 Smoking more than 5 cigarettes per day within 3 months before the trial;
- 12 Positive breath alcohol test or history of alcoholism (14 units of alcohol per week: 1 unit = 360 mL of beer or 45 mL of spirits with 40% alcohol or 150 mL of wine);
- 13 Drug screening positive or drug use 3 months before the trial;
- 14 Inability to tolerate venipuncture for blood sampling or poor vascular status;
- 15 Subjets cannot complete the trial due to personal reasons;
- 16 Other conditions considered inappropriate by the investigator.
Key Trial Info
Start Date :
July 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2021
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT05344729
Start Date
July 6 2021
End Date
August 30 2021
Last Update
April 25 2022
Active Locations (1)
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1
Affiliated Hospital of Changchun University of Traditional Chinese Medicine
Changchun, Jilin, China, 130021