Acute Coronary SyndromePhase 1NCT06584812

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

A Phase 1 study testing Tiprogrel, Clopidogrel and Ticagrelor in people with Acute Coronary Syndrome and Ischemic Stroke, run by Tianjin Institute of Pharmaceutical Research Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Acute Coronary Syndrome, Ischemic Stroke
What is being tested?: Tiprogrel, Clopidogrel and Ticagrelor
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteChina
Study dates: 9 Sep 2024to 17 Dec 2024
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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

Show all 24Show fewer

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing Tiantan Hosptial, Capital Medical University
Beijing

Other trials in China

About this study

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

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

Read the 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 compare pharmacokinetics /pharmacodynamic of Tiprogrel,Clopidogrel and Ticagrelor.

Conditions: Acute Coronary Syndrome, Ischemic Stroke
Being tested: Tiprogrel, Clopidogrel, Ticagrelor
Medical subject headings: Acute Coronary Syndrome, Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TiprogrelDrug
Period 1: Dose 1 Tiprogrel, loading dose of Tiprogrel followed by daily maintenance dose until Day 8.
TiprogrelDrug
Period 2: Dose 2 Tiprogrel ; loading dose of Tiprogrel followed by daily maintenance dose until Day 8.
ClopidogrelDrug
Period 3: Clopidogrel; loading dose of Clopidogrel followed by daily maintenance dose until Day 8.
TicagrelorDrug
Period 4: Ticagrelor; loading dose of Ticagrelor followed by daily maintenance dose until Day 8.

Study groups in NCT06584812
Study group	Role	What they receive
Tiprogrel-Clopidogrel-Ticagrelor	Other	Period 1: Dose 1 Tiprogrel; Period 2: Dose 2 Tiprogrel ; Period 3: Clopidogrel; Period 4: Ticagrelor Receives: Drug: Tiprogrel; Drug: Clopidogrel; Drug: Ticagrelor

What is being measured

The primary outcome is the main question the study is designed to answer.

PK parameters： Cmax
Maximum Concentration of Tiprogrel 's active metabolite
Measured: Day 1 to Day 9 in each period
PK parameters： Cmax
Maximum Concentration of Clopidogrel 's active metabolite
Measured: Day 1 to Day 9 in each period
PK parameters： AUC
Area under the plasma concentration curve of Tiprogrel 's active metabolite
Measured: Day 1 to Day 9 in each period
PK parameters： AUC
Area under the plasma concentration curve of Clopidogrel 's active metabolite
Measured: Day 1 to Day 9 in each period
PK parameters： Tmax
Time to maximum concentration of Tiprogrel 's active metabolite
Measured: Day 1 to Day 9 in each period
PK parameters： Tmax
Time to maximum concentration of Clopidogrel 's active metabolite
Measured: Day 1 to Day 9 in each period
PK parameters： T1/2
Half life of Tiprogrel 's active metabolite
Measured: Day 1 to Day 9 in each period
PK parameters： T1/2
Half life of Clopidogrel 's active metabolite
Measured: Day 1 to Day 9 in each period
PD parameters: Adenosine Diphosphate(ADP)-induced P2Y12 Receptor-mediated platelet aggregation of Tiprogrel
ADP-induced platelet reaction unit represents the rate and extent of ADP-stimulated platelet aggregation
Measured: Day 1 to Day 14 in each period
PD parameters: Adenosine Diphosphate(ADP)-induced P2Y12 Receptor-mediated platelet aggregation of Clopidogrel
ADP-induced platelet reaction unit represents the rate and extent of ADP-stimulated platelet aggregation
Measured: Day 1 to Day 14 in each period
PD parameters: Adenosine Diphosphate(ADP)-induced P2Y12 Receptor-mediated platelet aggregation of Ticagrelor
ADP-induced platelet reaction unit represents the rate and extent of ADP-stimulated platelet aggregation
Measured: Day 1 to Day 14 in each period
Safety parameters: Number of Participants With Treatment-Related Adverse Events
Measured: Day 1 to Day 14 in each period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Sep 202417 Dec 2024

First posted5 Sep 2024
Study start9 Sep 2024
Primary completion5 Dec 2024
Study completion17 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06584812
Sponsor's protocol ID: TY601A-P1-03
Status last verified: Jan 2025
First submitted: 29 Aug 2024
Last updated: 6 Jan 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Coronary Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety in Healthy Subjects with Multiple Administration of Tiprogrel
ClinicalTrials.gov ID: NCT06584812
Acronym / sponsor ID: TY601A-P1-03
Conditions: Acute Coronary Syndrome, Ischemic Stroke
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Tianjin Institute of Pharmaceutical Research Co., LtdOther government
Study start: 9 Sep 2024 (actual)
Primary completion: 5 Dec 2024 (actual)
Study completion: 17 Dec 2024 (actual)
First posted: 5 Sep 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Tiprogrel-Clopidogrel-Ticagrelor	Other	Drug: Tiprogrel, Drug: Clopidogrel, Drug: TicagrelorPeriod 1: Dose 1 Tiprogrel; Period 2: Dose 2 Tiprogrel ; Period 3: Clopidogrel; Period 4: Ticagrelor

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (24 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TiprogrelPeriod 1: Dose 1 Tiprogrel, loading dose of Tiprogrel followed by daily maintenance dose until Day 8.	Drug	Tiprogrel-Clopidogrel-Ticagrelor
TiprogrelPeriod 2: Dose 2 Tiprogrel ; loading dose of Tiprogrel followed by daily maintenance dose until Day 8.	Drug	Tiprogrel-Clopidogrel-Ticagrelor
ClopidogrelPeriod 3: Clopidogrel; loading dose of Clopidogrel followed by daily maintenance dose until Day 8.	Drug	Tiprogrel-Clopidogrel-Ticagrelor
TicagrelorPeriod 4: Ticagrelor; loading dose of Ticagrelor followed by daily maintenance dose until Day 8.	Drug	Tiprogrel-Clopidogrel-Ticagrelor

Primary outcome

PK parameters： Cmax
Time frame: Day 1 to Day 9 in each period
Maximum Concentration of Tiprogrel 's active metabolite
PK parameters： Cmax
Time frame: Day 1 to Day 9 in each period
Maximum Concentration of Clopidogrel 's active metabolite
PK parameters： AUC
Time frame: Day 1 to Day 9 in each period
Area under the plasma concentration curve of Tiprogrel 's active metabolite
PK parameters： AUC
Time frame: Day 1 to Day 9 in each period
Area under the plasma concentration curve of Clopidogrel 's active metabolite
PK parameters： Tmax
Time frame: Day 1 to Day 9 in each period
Time to maximum concentration of Tiprogrel 's active metabolite
PK parameters： Tmax
Time frame: Day 1 to Day 9 in each period
Time to maximum concentration of Clopidogrel 's active metabolite
PK parameters： T1/2
Time frame: Day 1 to Day 9 in each period
Half life of Tiprogrel 's active metabolite
PK parameters： T1/2
Time frame: Day 1 to Day 9 in each period
Half life of Clopidogrel 's active metabolite
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
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
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
Safety parameters: Number of Participants With Treatment-Related Adverse Events
Time frame: Day 1 to Day 14 in each period

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
Individual participant dataSharing planned: No

Related trials for Acute Coronary Syndrome

Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
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AI-Assisted Interpretation of Cardiac CT in the Emergency Department
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Optical Coherence Tomography in Acute Vessel Evaluation
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PK parameters： Cmax (time frame: Day 1 to Day 9 in each period). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06584812.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.