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

NCT03092076 | Completed Phase 1

• 1 other identifier: GDREC2015143H(R1)
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy

Keywords

pharmacokinetics; antiplatelet effects; single nucleotide polymorphism (SNP)

Outcome Measures

Primary Outcomes (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 .

  10 weeks

Secondary Outcomes (5)

• ADP-stimulated platelet aggregation

  8 weeks

• Peak plasma concentration (Cmax)

  10 weeks

• Time to peak plasma concentration (tmax)

  10 weeks

• Area under the plasma concentration-time curve (AUC)

  10 weeks

• Accumulated amount of ticagrelor and its metabolites in urine

  10 weeks

Study Arms (3)

Pharmacokinetics

EXPERIMENTAL

The pharmacokinetics characteristic of ticagrelor in healthy Chinese is investigated to provide the basis for its efficacy and safety of clinical treatment.

Drug: Ticagrelor

Antiplatelet effects

EXPERIMENTAL

The antiplatelet effects of ticagrelor in healthy Chinese is investigated to provide the basis for its efficacy and safety of clinical treatment.

Drug: Ticagrelor

The impact of genotype

NO INTERVENTION

The 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.

Interventions

Ticagrelor DRUG

180 mg loading dose

Also known as: Brilinta, AstraZeneca

Antiplatelet effects; Pharmacokinetics

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Related Publications (3)

• 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.

  PMID: 40682019 DERIVED

• 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.

  PMID: 35574651 DERIVED

• 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.

  PMID: 30936830 DERIVED

MeSH Terms

Interventions

Ticagrelor; ChAdOx1 nCoV-19

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Vaccines, DNA; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines

Study Officials

• Shilong Zhong, Ph.D

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 9, 2017
• First Posted: March 27, 2017
• Study Start: May 20, 2015
• Primary Completion: October 24, 2015
• Study Completion: June 16, 2016
• Last Updated: March 27, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share