Status:
COMPLETED
Study to Assess Pharmacokinetics, Pharmacodynamics and Safety of Tiprogrel in Healthy Subjects
Lead Sponsor:
Tianjin Institute of Pharmaceutical Research Co., Ltd
Conditions:
Acute Coronary Syndrome
Ischemic Stroke
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
This study is designed to evaluate the pharmacokinetics, pharmacodynamics and safety in healthy subjects with multiple administration of Tiprogrel.
Detailed Description
Tiprogrel is a novel oral P2Y12 receptor antagonist.This study is to evaluate the pharmacokinetics, pharmacodynamics and safety in healthy subjects with multiple administration of Tiprogrel, and compa...
Eligibility Criteria
Inclusion
- Male and female Healthy Subjects
- Subject has the ability and willingness to comply with study procedures and follow-up examination.
- 3：18 to 50 years of age (including the threshold) 4: Body mass index (BMI) ≥ 19.0 to ≤ 28.0 kg/m2; total body weight of male subject ≥ 50 kg at Screening; total body weight of female subject ≥ 45 kg at Screening; 5：Medically healthy based on their medical history, and physical examination, clinical laboratory test results, ECGs, and vital sign measurements as determined by the Investigator at Screening; 6: Female subjects are not pregnant or breastfeeding, and the fertile female and male subjects must agree to follow instructions for method(s) of contraception.
Exclusion
- History or presence of metabolic, allergy, dermatology, liver, kidney, hematology, cardiovascular, gastrointestinal, nervous, respiratory, endocrine or psychiatric diseases.
- History or presence of obviously active bleeding, or coagulation or bleeding disorders, or any skin petechiae, or thrombus, or spontaneous bleeding.
- Subject with history of allergy to a variety of drugs, or has a known or suspected hypersensitivity to tiprogrel or other anti-platelet drugs
- Subjects who had a history of major surgery within 3 months before the trial or planned to undergo surgery during the study period.
- Subjects who have lost or donated ≥ 400 mL blood or received blood transfusion or used blood products within three months, or subjects with clinically significant anemia based on the judgment of the Investigator
- Subjects with systolic blood pressure of \> 140 mmHg or \< 90 mmHg, diastolic blood pressure of \> 90 mmHg or \< 60 mmHg
- Subjects with 12-lead ECG examination: QTcF \> 450 msec
- Platelet count (PLT) value, beyond the laboratory's reference range
- Activated partial thromboplastin time (APTT) and Prothrombin Time (PT), beyond the laboratory's reference range
- ALT, AST, γ-GGT, ALP and TBIL value \>1.5 times the upper limit of normal value
- Subjects with positive results at screening for HIV, syphilis, HBsAg, or HCV
- Subjects who have taken aspirin/other nonsteroidal anti-inflammatory drugs (NSAIDs) or other drugs that may affect coagulation function within 2 weeks before the trial
- Subjects who have taken prescription drugs/products or herbs within 2 weeks or 5 half-lives (whichever is longer) before the trial;or taken OTC drugs/products within 7 days before the trial.
- Subjects who have received live or attenuated vaccines within 1 month prior to receiving the study drug or expected to receive vaccines during the study period
- Subjects who have ingested investigational drug within 3 months or 5 half-lives prior to the first study drug dose
- Subjects who have participated in another clinical trial within 3 months or 5 half-lives prior to the first study drug dose;
- Consumption of any known liver enzyme inducers/inhibitors within 30 days prior to the first study drug dose;
- Have a history of drug addiction or drug abuse within 1 year prior to screening;
- Positive results for alcohol, or cotinine, or urine for drugs test in screening or admission;
- Subject with alcohol consumption defined as \> 21 units per week for men and \> 14 units per week for woman;
- Use of tobacco or nicotine-containing products within 1 month prior to screening;
- CYP2C19 poor metabolizer;
- Subjects with a history of fainting needle or blood;
- Subjects who are not suitable to participate in this experiment.
Key Trial Info
Start Date :
September 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 17 2024
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT06584812
Start Date
September 9 2024
End Date
December 17 2024
Last Update
January 6 2025
Active Locations (1)
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1
Beijing Tiantan Hosptial, Capital Medical University
Beijing, China