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HealthyPhase 1IGPPTNCT03092076

The Impact of Genotype on Pharmacokinetics and Antiplatelet Effects of Ticagrelor in Healthy Chinese

A Phase 1 study testing Ticagrelor in people with Healthy, run by Guangdong Provincial People's Hospital.

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 a open and single center clinical trial in healthy Chinese.The objective of the study is to clarify the pharmacokinetics characteristics and antiplatelet effects of ticagrelor in Chinese and to investigate the impact of genotype. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Ticagrelor
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
No sites listed yet
Study dates
20 May 2015to 16 Jun 2016
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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age: 18 - 45 years;
  • Sex: male and female;
  • Ethnicity: Chinese;
  • Good health as evidenced by the results of physical examination, vitals signs, electrocardiogram, and clinical laboratory test results, but there were exceptions if an abnormal value was considered not to be clinical significance;
  • Written informed consent.

Who cannot join

  • Any conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs;
  • Intolerance or hypersensitivity to drugs whose mechanism is similar to that of ticagrelor;
  • Any history of taking medicines within half a month before enrollment;
  • Any history of whole blood transfusion within 2 months, blood elements transfusion or blood donation within 1 months before enrollment;
  • Participation in a clinical study within 3 months before enrollment;
  • Abuse of caffeine (> 5 units/day), alcohol(> 21 units /week), smoking(> 10 cigarettes/day);
  • Positive serology for Hbs antigen and HIV;
  • History of coagulation disorders.

About this study

This study is a open and single center clinical trial in healthy Chinese.The objective of the study is to clarify the pharmacokinetics characteristics and antiplatelet effects of ticagrelor in Chinese and to investigate the impact of genotype.

Read the detailed description

This is an open-label, single-does, nonrandomized study of ticagrelor in healthy volunteers carried out at a single center. Written informed consent will be obtained from all volunteers before initiation of the study. The study is approved by the Research Ethic Committee of Guangdong General Hospital. Fifty-one healthy Chinese will be recruited.

Venous blood will be collected at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48h after taking 180mg ticagrelor orally. Urine collection intervals are at predose and 0 to 2, 2 to 4, 4 to 6, 6 to 9, 9 to 12, 12 to 16 and 16 to 24h after dosing. The concentration of ticagrelor and its metabolites will be analyzed using a separately validated liquid chromatography technique with tandem mass spectrometric detection (LC-MS/MS).

Besides，the basic principle of population pharmacodynamics(PPD) is applied to evaluate antiplatelet effects. Adenosine diphosphate(ADP)-stimulated platelet aggregation will be assessed at baseline, and 0.5h/1h, 2h, 4h/8h/24h, 48h/3d/5d and 7d after dosing.

The effects of genetic variants on antiplatelet and pharmacokinetic response to ticagrelor are investigated through a genome-wide association study (GWAS).

Conditions
Healthy
Being tested
Ticagrelor
Keywords
pharmacokinetics, antiplatelet effects, single nucleotide polymorphism (SNP)

What participants receive

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

  • TicagrelorDrug

    Also called Brilinta, AstraZeneca

    180 mg loading dose

Study groups in NCT03092076
Study groupRoleWhat they receive
PharmacokineticsExperimentalThe pharmacokinetics characteristic of ticagrelor in healthy Chinese is investigated to provide the basis for its efficacy and safety of clinical treatment.
Receives: Drug: Ticagrelor
Antiplatelet effectsExperimentalThe antiplatelet effects of ticagrelor in healthy Chinese is investigated to provide the basis for its efficacy and safety of clinical treatment.
Receives: Drug: Ticagrelor
The impact of genotypeNo interventionThe recovery time of platelet function following the administration of ticagrelor is widely varied that genetic variants maybe an underlying factor.The impact of genotype on pharmacokinetic parameters and ADP of ticagrelor is compared among different genotypes.

What is being measured

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

  1. Genome-wide genotyping in 51 healthy Chinese

    A total of 900,015 SNPs in a GWAS scan were genotyped with the Illumina HumanOmniZhongHua-8 BeadChip according to the protocol from Illumina. Prior to association analysis, a systematic quality control (QC) procedure was applied to the raw genotyping data to filter unqualified SNPs and samples. The effects of genetic variants on antiplatelet and pharmacokinetic response to ticagrelor are investigated through a genome-wide association study（GWAS）in 51 healthy Chinese .

    Measured: 10 weeks

Secondary outcomes (5)

  1. ADP-stimulated platelet aggregation

    For platelet function tests, ADP-stimulated platelet aggregation was measured in ethylenediaminetetraacetic acid (EDTA) anticoagulated whole blood samples (2 x 2 mL) within 2 h of sampling using a Chrono-log Platelet Aggregation Systems. The platelet aggregation (PA) postdose till recovery to baseline was measured by light transmission method using ADP (20 μmol/L final concentration), and expressed as percentages. Since a sparse sampling design for platelet function testing was used, the missing platelet aggregation data during the recovery of platelet function were imputed using Bayesian simulation method. The time recovering 50% of maximum drug effect (RT50) were estimated individually, which were used to represent the antiplatelet effect.

    Measured: 8 weeks

  2. Peak plasma concentration (Cmax)

    A LC-MS/MS assay was developed and validated for simultaneous determination of ticagrelor, its metabolites, and internal standard (ferulic acid) in human plasma. Plasma samples were extracted with ethyl acetate. Peak plasma concentration (Cmax) of ticagrelor and M8 were estimated for each subject, using the non-compartmental analysis function in Phoenix WinNonlin software, version 6.3.

    Measured: 10 weeks

  3. Time to peak plasma concentration (tmax)

    A LC-MS/MS assay was developed and validated for simultaneous determination of ticagrelor, its metabolites, and internal standard (ferulic acid) in human plasma. Plasma samples were extracted with ethyl acetate. Time to peak plasma concentration (tmax) of ticagrelor and M8 were estimated for each subject, using the non-compartmental analysis function in Phoenix WinNonlin software, version 6.3.

    Measured: 10 weeks

  4. Area under the plasma concentration-time curve (AUC)

    A LC-MS/MS assay was developed and validated for simultaneous determination of ticagrelor, its metabolites, and internal standard (ferulic acid) in human plasma. Plasma samples were extracted with ethyl acetate. Area under the plasma concentration-time curve (AUC) of ticagrelor and M8 were estimated for each subject, using the non-compartmental analysis function in Phoenix WinNonlin software, version 6.3.

    Measured: 10 weeks

  5. Accumulated amount of ticagrelor and its metabolites in urine

    A LC-MS/MS assay was developed and validated for simultaneous determination of ticagrelor, its metabolites, and internal standard (gliclazide) in human urine. Urine samples were precipitated with 50% methanol/acetonitrile. Accumulated amount of ticagrelor and its metabolites in urine over 24 h was calculated. The relative accumulated amount was the product of the relative index and the urine volume (Compound/IS x Vurine).

    Measured: 10 weeks

Timeline

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

  1. First posted27 Mar 2017
  2. Study start20 May 2015
  3. Primary completion24 Oct 2015
  4. Study completion16 Jun 2016

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03092076
Sponsor's protocol ID
GDREC2015143H(R1)
Acronym
IGPPT
Status last verified
Mar 2017
First submitted
9 Mar 2017
Last updated
27 Mar 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Chen J, Xu G, Xie Z, Xie S, Luo W, Zhong S, Lai W. GPD2 inhibition impairs coagulation function via ROS/NF-kappaB/P2Y12 pathway. Cell Mol Biol Lett. 2025 Jul 18;30(1):84. doi: 10.1186/s11658-025-00759-x.

    PubMed 40682019

  • Xu G, Liu JE, Liu X, Zhong W, Wang Z, Li H, Xiao X, Chen J, Zhong S, Lai W. DNA methylation mediates the genetic variants on ticagrelor major metabolite elimination and platelet function recovery after ticagrelor discontinuation. Epigenomics. 2022 May;14(10):601-613. doi: 10.2217/epi-2021-0461. Epub 2022 May 16.

    PubMed 35574651

  • Zhu Q, Zhong W, Wang X, Mai L, He G, Chen J, Tang L, Liu S, Lai W, Zhong S. Pharmacokinetic and Pharmacogenetic Factors Contributing to Platelet Function Recovery After Single Dose of Ticagrelor in Healthy Subjects. Front Pharmacol. 2019 Mar 18;10:209. doi: 10.3389/fphar.2019.00209. eCollection 2019.

    PubMed 30936830

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ticagrelor in people with Healthy, run by Guangdong Provincial People's Hospital.

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 5 inclusion and 8 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 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

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?

Genome-wide genotyping in 51 healthy Chinese (time frame: 10 weeks). 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 NCT03092076, which also lists 3 linked publications.

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 27 Mar 2017.

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