Study to Assess Pharmacokinetics, Pharmacodynamics and Safety of Tiprogrel in Healthy Subjects
NCT ID: NCT06584812
Last Updated: 2025-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
14 participants
INTERVENTIONAL
2024-09-09
2024-12-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of Low-Dose, Standard-Dose Ticagrelor and Clopidogrel for Inhibition of Platelet Reactivity in Patients With Acute Coronary Syndromes
NCT02319941
Platelet Reactivity in Acute Non-disabling Cerebrovascular Events
NCT02506140
Evaluation of Antiplatelet Effects and Safety of Intraoperative Administration of Ticagrelor Versus Clopidogrel
NCT02513004
Clopidogrel And Ticagrelor in Healthy Subjects
NCT02086903
The Effect of Ticagrelor or Clopidogrel on Endothelial Function During Acute and Chronic Treatment
NCT02580149
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SEQUENTIAL
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Tiprogrel-Clopidogrel-Ticagrelor
Period 1: Dose 1 Tiprogrel; Period 2: Dose 2 Tiprogrel ; Period 3: Clopidogrel; Period 4: Ticagrelor
Tiprogrel
Period 1: Dose 1 Tiprogrel, loading dose of Tiprogrel followed by daily maintenance dose until Day 8.
Tiprogrel
Period 2: Dose 2 Tiprogrel ; loading dose of Tiprogrel followed by daily maintenance dose until Day 8.
Clopidogrel
Period 3: Clopidogrel; loading dose of Clopidogrel followed by daily maintenance dose until Day 8.
Ticagrelor
Period 4: Ticagrelor; loading dose of Ticagrelor followed by daily maintenance dose until Day 8.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tiprogrel
Period 1: Dose 1 Tiprogrel, loading dose of Tiprogrel followed by daily maintenance dose until Day 8.
Tiprogrel
Period 2: Dose 2 Tiprogrel ; loading dose of Tiprogrel followed by daily maintenance dose until Day 8.
Clopidogrel
Period 3: Clopidogrel; loading dose of Clopidogrel followed by daily maintenance dose until Day 8.
Ticagrelor
Period 4: Ticagrelor; loading dose of Ticagrelor followed by daily maintenance dose until Day 8.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. 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 Criteria
2. History or presence of obviously active bleeding, or coagulation or bleeding disorders, or any skin petechiae, or thrombus, or spontaneous bleeding.
3. Subject with history of allergy to a variety of drugs, or has a known or suspected hypersensitivity to tiprogrel or other anti-platelet drugs
4. Subjects who had a history of major surgery within 3 months before the trial or planned to undergo surgery during the study period.
5. 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
6. Subjects with systolic blood pressure of \> 140 mmHg or \< 90 mmHg, diastolic blood pressure of \> 90 mmHg or \< 60 mmHg
7. Subjects with 12-lead ECG examination: QTcF \> 450 msec
8. Platelet count (PLT) value, beyond the laboratory's reference range
9. Activated partial thromboplastin time (APTT) and Prothrombin Time (PT), beyond the laboratory's reference range
10. ALT, AST, γ-GGT, ALP and TBIL value \>1.5 times the upper limit of normal value
11. Subjects with positive results at screening for HIV, syphilis, HBsAg, or HCV
12. 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
13. 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.
14. 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
15. Subjects who have ingested investigational drug within 3 months or 5 half-lives prior to the first study drug dose
16. Subjects who have participated in another clinical trial within 3 months or 5 half-lives prior to the first study drug dose;
17. Consumption of any known liver enzyme inducers/inhibitors within 30 days prior to the first study drug dose;
18. Have a history of drug addiction or drug abuse within 1 year prior to screening;
19. Positive results for alcohol, or cotinine, or urine for drugs test in screening or admission;
20. Subject with alcohol consumption defined as \> 21 units per week for men and \> 14 units per week for woman;
21. Use of tobacco or nicotine-containing products within 1 month prior to screening;
22. CYP2C19 poor metabolizer;
23. Subjects with a history of fainting needle or blood;
24. Subjects who are not suitable to participate in this experiment.
18 Years
50 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tianjin Institute of Pharmaceutical Research Co., Ltd
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beijing Tiantan Hosptial, Capital Medical University
Beijing, , China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TY601A-P1-03
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.