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Completed

NCT Number: NCT06584812

Study to Assess Pharmacokinetics, Pharmacodynamics and Safety of Tiprogrel in Healthy Subjects

This study is designed to evaluate the pharmacokinetics, pharmacodynamics and safety in healthy subjects with multiple administration of Tiprogrel.

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Key information

Conditions

Acute Coronary Syndrome Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Ischemic Stroke Myocardial Ischemia Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Tiantan Hosptial, Capital Medical University

Beijing, China

About this study

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 compare pharmacokinetics /pharmacodynamic of Tiprogrel,Clopidogrel and Ticagrelor.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Tiprogrel

Drug

Period 1: Dose 1 Tiprogrel, loading dose of Tiprogrel followed by daily maintenance dose until Day 8.

clopidogrel

Drug

Period 3: Clopidogrel; loading dose of Clopidogrel followed by daily maintenance dose until Day 8.

Ticagrelor

Drug

Period 4: Ticagrelor; loading dose of Ticagrelor followed by daily maintenance dose until Day 8.

Primary outcomes

  1. PK parameters： Cmax

    Time frame: Day 1 to Day 9 in each period

    Maximum Concentration of Tiprogrel 's active metabolite

  2. PK parameters： Cmax

    Time frame: Day 1 to Day 9 in each period

    Maximum Concentration of Clopidogrel 's active metabolite

  3. PK parameters： AUC

    Time frame: Day 1 to Day 9 in each period

    Area under the plasma concentration curve of Tiprogrel 's active metabolite

  4. PK parameters： AUC

    Time frame: Day 1 to Day 9 in each period

    Area under the plasma concentration curve of Clopidogrel 's active metabolite

  5. PK parameters： Tmax

    Time frame: Day 1 to Day 9 in each period

    Time to maximum concentration of Tiprogrel 's active metabolite

  6. PK parameters： Tmax

    Time frame: Day 1 to Day 9 in each period

    Time to maximum concentration of Clopidogrel 's active metabolite

  7. PK parameters： T1/2

    Time frame: Day 1 to Day 9 in each period

    Half life of Tiprogrel 's active metabolite

  8. PK parameters： T1/2

    Time frame: Day 1 to Day 9 in each period

    Half life of Clopidogrel 's active metabolite

  9. PD parameters: Adenosine Diphosphate(ADP)-induced P2Y12 Receptor-mediated platelet aggregation of Tiprogrel

    Time frame: Day 1 to Day 14 in each period

    ADP-induced platelet reaction unit represents the rate and extent of ADP-stimulated platelet aggregation

  10. PD parameters: Adenosine Diphosphate(ADP)-induced P2Y12 Receptor-mediated platelet aggregation of Clopidogrel

    Time frame: Day 1 to Day 14 in each period

    ADP-induced platelet reaction unit represents the rate and extent of ADP-stimulated platelet aggregation

  11. PD parameters: Adenosine Diphosphate(ADP)-induced P2Y12 Receptor-mediated platelet aggregation of Ticagrelor

    Time frame: Day 1 to Day 14 in each period

    ADP-induced platelet reaction unit represents the rate and extent of ADP-stimulated platelet aggregation

  12. Safety parameters: Number of Participants With Treatment-Related Adverse Events

    Time frame: Day 1 to Day 14 in each period

Sponsors and collaborators

Lead sponsor

Tianjin Institute of Pharmaceutical Research Co., Ltd

Other Gov

Registry information

Official study title

A Phase I Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety in Healthy Subjects with Multiple Administration of Tiprogrel

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 5, 2024
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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