Back to resultsTicagrelor China Pharmacokinetic/Pharmacodynamic Study
Primary Purpose
Stable Coronary Heart Disease (CHD)
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Inhibition of Platelet Aggregation by "Brilinta"(Ticagrelor)
Sponsored by
About this trial
This is an interventional treatment trial for Stable Coronary Heart Disease (CHD)
Eligibility Criteria
Inclusion Criteria:
- Provision of signed and dated written informed consent prior to any study specific procedures.
- Female or male Chinese (as defined by Chinese Regulatory) patients aged 18 years or older with suitable veins for cannulations or repeated venipunctures.
Documented stable coronary heart disease (CHD) fulfilling all of the following, and taking 75-100 mg ASA daily treatment:
Diagnosed stable angina pectoris per the guidance of Chinese Society of Cardiology published in 2007, patients with angina severity classified as I and II of Canadian Cardiovascular Society grading of angina pectoris.
- Female patients without pregnant potential
Exclusion Criteria:
- Any indication for oral anticoagulant or dual antiplatelet treatment and chronic ASA with doses greater than 100 mg/day.
- Concomitant therapy with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic index, or strong CYP3A inducers within 14 days preceding the first dose of study medication and during study treatment.
- Increased bleeding risk.
- Contraindication or other reason that ASA or ticagrelor should not be administered
- Patients that are scheduled for revascularization (eg, PCI, CABG) during the study period
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Ticagrelor 45mg
Ticagrelor 60mg
Ticagrelor 90mg
Arm Description
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
Outcomes
Primary Outcome Measures
IPA on Day 1
The Inhibition of Platelet Aggregation (IPA) profiles of single and multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease (CHD) on chronic low dose ASA (75-100mg daily).
Primary variable: IPA (final extent) induced by 20µM ADP at each assessment point after single and multiple doses of ticagrelor measured by Light-Transmittance Aggregometry (LTA).
IPA on Day 7
The inhibition of Platelet Aggregation (IPA) profiles of single and multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease (CHD) on chronic low dose ASA (75-100mg daily).
Primary variable: IPA (final extent) induced by 20µM ADP at each assessment point after single and multiple doses of ticagrelor measured by Light-Transmittance Aggregometry (LTA).
Secondary Outcome Measures
Percent Change From Baseline in PRU on Day 1
Percent Change from baseline in Platelet P2Y12 Reaction Units (PRU)(measured by VerifyNow) profiles of multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Pharmacokinetics Parameters of Ticagrelor on Day 7(1)
Pharmacokinetics parameters of Ticagrelor on Day 7---Cmax
Safety---Vital Signs Over Time---Blood Pressure
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Vital signs (seated blood pressure [BP])
Percent Change From Baseline in PRU on Day 7
Percent Change from baseline in Platelet P2Y12 Reaction Units (PRU)(measured by VerifyNow) profiles of multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease on chronic low dose ASA.
TIPA(Max)---Day 1
The time to peak IPA (TIPAmax) was estimated for ADP-induced final extent IPA.
TIPA(Max)---Day 7
The time to peak IPA (TIPAmax) was estimated for ADP-induced final extent IPA.
AUEC(Final Extent) on Day 1
The area-under-the-effect curve (AUEC) was estimated for ADP-induced final extent IPA.
AUEC(Final Extent) on Day 7
The area-under-the-effect curve (AUEC) was estimated for ADP-induced final extent IPA.
Pharmacokinetics Parameters of Ticagrelor on Day 1(3)
The pharmacokinetics parameter of ticagrelor on Day 1---tmax and t1/2
Pharmacokinetics Parameters of Ticagrelor on Day 1(2)
The pharmacokinetics parameters of Ticagrelor on Day 1---AUC(0-inf), AUC(0-12h) and AUC(0-t).
Pharmacokinetics Parameters of Ticagrelor on Day 7(2)
The pharmacokinetics parameters of ticagrelor on Day 7---tmax
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(1)
Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 1---Cmax
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(3)
Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 1: tmax and t1/2
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(1)
Pharmacokinetics parameters of Metabolite (AR-C124910XX) on Day 7---Cmax
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(4)
Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 7---tmax
Pharmacokinetics Parameters of Metabolite : Parent on Day 1--Cmax
To determine Cmax ratio for the metabolite to that of the parent compound on Day 1
Pharmacokinetics Parameters of Metabolite : Parent on Day 7---Cmax
To determine Cmax ratio of metabolite to that of the parent compound on Day 7
Safety---Physical Examination, Summary of Abnormalities
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Physical examination
Safety---Hematology Laboratory Variables Over Time---hematocrit
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Haematology---hematocrit
Safety---All Allowed Concomitant Medications During Study Treatment
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Concomitant medications
Safety---Causally Related Adverse Events by System Organ Class and Preferred Term
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Assessment of adverse events
Pharmacokinetics Parameters of Ticagrelor on Day 1(1)
The pharmacokinetics parameters of Ticagrelor on Day 1---Cmax
Pharmacokinetics Parameters of Ticagrelor on Day 7(3)
Pharmacokinetics parameters of Ticagrelor on Day 7---AUC(0-12h)
Pharmacokinetics Parameters of Ticagrelor on Day 7(4)
Pharmacokinetics parameters of Ticagrelor on Day 7---Accumulation ratio(ratio of Day 7 AUC(0-12h) to Day 1 AUC(0-12h))
Safety---Vital Signs Over Time---Height
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Vital signs (Height)
Safety---Vital Signs Over Time---Weight
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Vital signs (Weight)
Safety---Vital Signs Over Time---Pulse Rate
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Vital signs (Pulse Rate)
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(2)
Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 1---AUC(0-12h), AUC(0-t) and AUC(0-inf)
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(2)
Pharmacokinetics parameters of Metabolite (AR-C124910XX) on Day 7---AUC(0-12h)
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(3)
Pharmacokinetics parameters of Metabolite (AR-C124910XX) on Day 7---Accumulation ratio(ratio of Day 7 AUC(0-12h) to Day 1 AUC(0-12h))
Safety---Hematology Laboratory Variables Over Time---Erythrocytes
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Haematology---Erythrocytes
Safety---Hematology Laboratory Variables Over Time---Hemoglobin
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Haematology---Hemoglobin
Safety---Hematology Laboratory Variables Over Time---Leukocytes
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Haematology---Leukocytes
Safety---Hematology Laboratory Variables Over Time---Platelets
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Haematology---Platelets
Safety---Clinical Chemistry Variables Over Time---Glucose
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Clinical Chemistry---Glucose
Safety---Clinical Chemistry Variables Over Time---Alanine Aminotransferase
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Clinical Chemistry---Alanine Aminotransferase
Safety---Clinical Chemistry Variables Over Time---Aspartate Aminotransferase
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Clinical Chemistry---Aspartate Aminotransferase
Safety---Clinical Chemistry Variables Over Time---Alkaline Phosphatase
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Clinical Chemistry---Alkaline Phosphatase
Safety---Clinical Chemistry Variables Over Time---Creatinine
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Clinical Chemistry---Creatinine
Safety---Clinical Chemistry Variables Over Time---Total Bilirubin
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Clinical Chemistry---Total Bilirubin
Safety---Clinical Chemistry Variables Over Time---Sodium
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Clinical Chemistry---Sodium
Safety---Clinical Chemistry Variables Over Time---Potassium
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Clinical Chemistry---Potassium
Safety---Clinical Chemistry Variables Over Time---Chloride
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Clinical Chemistry---Chloride
Safety---Clinical Chemistry Variables Over Time---Phosphate
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Clinical Chemistry---Phosphate
Safety---Clinical Chemistry Variables Over Time---Albumin
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Clinical Chemistry---Albumin
Safety---Clinical Chemistry Variables Over Time---Protein
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Clinical Chemistry---Protein
Safety---Clinical Chemistry Variables Over Time---Blood Urea Nitrogen
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Clinical Chemistry---Blood Urea Nitrogen
Safety---Clinical Chemistry Variables Over Time---Bicarbonate
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Clinical Chemistry---Bicarbonate
Pharmacokinetics Parameters of Metabolite : Parent on Day 1--AUC(0-inf)
To determine AUC(0-inf) ratio for the metabolite to that of the parent compound on Day 1
Pharmacokinetics Parameters of Metabolite : Parent on Day 7---AUC(0-12h)
To determine AUC(0-12h) ratio of metabolite to that of the parent compound on Day 7.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02064985
Brief Title
Ticagrelor China Pharmacokinetic/Pharmacodynamic Study
Official Title
An Open Label, Single Centre, Randomised, Phase IV, Pharmacokinetic, Pharmacodynamic, and Safety Study to Evaluate Single and Multiple Doses of 45, 60, and 90 mg of Ticagrelor in Chinese Patients With Stable Coronary Heart Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
open label, single centre, randomised, Phase IV, pharmacokinetic, pharmacodynamic, and safety study to evaluate single and multiple doses of 45, 60, and 90 mg of ticagrelor in Chinese patients with stable coronary heart disease
Detailed Description
Up to 36 patients will be randomized in order to ensure 10 patients per treatment are evaluable.Ticagrelor will be supplied as 45 mg, 60mg, and 90mg tablets. Following an 8 hour fast on single dose on Day 1 and Day 7; on multiple doses from Day 3 to Day 6. Prior to the first dose of study drug there will be a screening period of maximum of 19 days. Patients will report to the clinical pharmacology unit (CPU) on Day -2 and will remain confined there until completion of study procedures on Day 7, the patients will be discharged on Day 8. In addition, patients will return to the CPU for a follow up visit 2 to 5 days after the last dose. Each patients participation, including the screening period, will take approximately 33 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Coronary Heart Disease (CHD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ticagrelor 45mg
Arm Type
Experimental
Arm Description
A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
Arm Title
Ticagrelor 60mg
Arm Type
Experimental
Arm Description
A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
Arm Title
Ticagrelor 90mg
Arm Type
Experimental
Arm Description
A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
Intervention Type
Drug
Intervention Name(s)
Inhibition of Platelet Aggregation by "Brilinta"(Ticagrelor)
Other Intervention Name(s)
"Brilinta"(Ticagrelor)
Intervention Description
To determine the Inhibition of Platelet Aggregation (IPA) profiles of single and multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease (CHD) on chronic low dose ASA (75-100mg daily).
Primary Outcome Measure Information:
Title
IPA on Day 1
Description
The Inhibition of Platelet Aggregation (IPA) profiles of single and multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease (CHD) on chronic low dose ASA (75-100mg daily).
Primary variable: IPA (final extent) induced by 20µM ADP at each assessment point after single and multiple doses of ticagrelor measured by Light-Transmittance Aggregometry (LTA).
Time Frame
Baseline and at 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours, 36 hours,48 hours after dose intake on Day 1
Title
IPA on Day 7
Description
The inhibition of Platelet Aggregation (IPA) profiles of single and multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease (CHD) on chronic low dose ASA (75-100mg daily).
Primary variable: IPA (final extent) induced by 20µM ADP at each assessment point after single and multiple doses of ticagrelor measured by Light-Transmittance Aggregometry (LTA).
Time Frame
Baseline and at 0 hour, 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours after dose intake on Day 7
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in PRU on Day 1
Description
Percent Change from baseline in Platelet P2Y12 Reaction Units (PRU)(measured by VerifyNow) profiles of multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Time Frame
Baseline and at 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours, 36 hours,48 hours after dose intake on Day 1
Title
Pharmacokinetics Parameters of Ticagrelor on Day 7(1)
Description
Pharmacokinetics parameters of Ticagrelor on Day 7---Cmax
Time Frame
Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7
Title
Safety---Vital Signs Over Time---Blood Pressure
Description
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Vital signs (seated blood pressure [BP])
Time Frame
Baseline, Day 1 to Day 7 and 2 to 5 days after last dose
Title
Percent Change From Baseline in PRU on Day 7
Description
Percent Change from baseline in Platelet P2Y12 Reaction Units (PRU)(measured by VerifyNow) profiles of multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Time Frame
Baseline and at 0 hour, 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours after dose intake on Day 7
Title
TIPA(Max)---Day 1
Description
The time to peak IPA (TIPAmax) was estimated for ADP-induced final extent IPA.
Time Frame
Day 1
Title
TIPA(Max)---Day 7
Description
The time to peak IPA (TIPAmax) was estimated for ADP-induced final extent IPA.
Time Frame
Day 7
Title
AUEC(Final Extent) on Day 1
Description
The area-under-the-effect curve (AUEC) was estimated for ADP-induced final extent IPA.
Time Frame
IPA was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1
Title
AUEC(Final Extent) on Day 7
Description
The area-under-the-effect curve (AUEC) was estimated for ADP-induced final extent IPA.
Time Frame
IPA was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7
Title
Pharmacokinetics Parameters of Ticagrelor on Day 1(3)
Description
The pharmacokinetics parameter of ticagrelor on Day 1---tmax and t1/2
Time Frame
Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1
Title
Pharmacokinetics Parameters of Ticagrelor on Day 1(2)
Description
The pharmacokinetics parameters of Ticagrelor on Day 1---AUC(0-inf), AUC(0-12h) and AUC(0-t).
Time Frame
Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1
Title
Pharmacokinetics Parameters of Ticagrelor on Day 7(2)
Description
The pharmacokinetics parameters of ticagrelor on Day 7---tmax
Time Frame
Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7
Title
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(1)
Description
Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 1---Cmax
Time Frame
Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1
Title
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(3)
Description
Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 1: tmax and t1/2
Time Frame
Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1
Title
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(1)
Description
Pharmacokinetics parameters of Metabolite (AR-C124910XX) on Day 7---Cmax
Time Frame
Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7
Title
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(4)
Description
Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 7---tmax
Time Frame
Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7
Title
Pharmacokinetics Parameters of Metabolite : Parent on Day 1--Cmax
Description
To determine Cmax ratio for the metabolite to that of the parent compound on Day 1
Time Frame
Day 1
Title
Pharmacokinetics Parameters of Metabolite : Parent on Day 7---Cmax
Description
To determine Cmax ratio of metabolite to that of the parent compound on Day 7
Time Frame
Day 7
Title
Safety---Physical Examination, Summary of Abnormalities
Description
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Physical examination
Time Frame
2 to 5 days after last dose
Title
Safety---Hematology Laboratory Variables Over Time---hematocrit
Description
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Haematology---hematocrit
Time Frame
2 to 5 days after last dose
Title
Safety---All Allowed Concomitant Medications During Study Treatment
Description
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Concomitant medications
Time Frame
All allowed concomitant medications during study treatment(up to 2-5 days after last dose), includes medications that began prior to randomization but were ongoing after randomization.
Title
Safety---Causally Related Adverse Events by System Organ Class and Preferred Term
Description
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Assessment of adverse events
Time Frame
Includes adverse events with an onset date on or after the date of first dose and up to and including the last study visit (up to 2-5 days after last dose).
Title
Pharmacokinetics Parameters of Ticagrelor on Day 1(1)
Description
The pharmacokinetics parameters of Ticagrelor on Day 1---Cmax
Time Frame
Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1
Title
Pharmacokinetics Parameters of Ticagrelor on Day 7(3)
Description
Pharmacokinetics parameters of Ticagrelor on Day 7---AUC(0-12h)
Time Frame
Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7
Title
Pharmacokinetics Parameters of Ticagrelor on Day 7(4)
Description
Pharmacokinetics parameters of Ticagrelor on Day 7---Accumulation ratio(ratio of Day 7 AUC(0-12h) to Day 1 AUC(0-12h))
Time Frame
Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7
Title
Safety---Vital Signs Over Time---Height
Description
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Vital signs (Height)
Time Frame
Baseline
Title
Safety---Vital Signs Over Time---Weight
Description
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Vital signs (Weight)
Time Frame
Baseline
Title
Safety---Vital Signs Over Time---Pulse Rate
Description
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Vital signs (Pulse Rate)
Time Frame
Baseline, Day 1 to Day 7 and 2 to 5 days after last dose
Title
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(2)
Description
Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 1---AUC(0-12h), AUC(0-t) and AUC(0-inf)
Time Frame
Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1
Title
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(2)
Description
Pharmacokinetics parameters of Metabolite (AR-C124910XX) on Day 7---AUC(0-12h)
Time Frame
Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7
Title
Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(3)
Description
Pharmacokinetics parameters of Metabolite (AR-C124910XX) on Day 7---Accumulation ratio(ratio of Day 7 AUC(0-12h) to Day 1 AUC(0-12h))
Time Frame
Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7
Title
Safety---Hematology Laboratory Variables Over Time---Erythrocytes
Description
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Haematology---Erythrocytes
Time Frame
2 to 5 days after last dose
Title
Safety---Hematology Laboratory Variables Over Time---Hemoglobin
Description
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Haematology---Hemoglobin
Time Frame
2 to 5 days after last dose
Title
Safety---Hematology Laboratory Variables Over Time---Leukocytes
Description
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Haematology---Leukocytes
Time Frame
2 to 5 days after last dose
Title
Safety---Hematology Laboratory Variables Over Time---Platelets
Description
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Haematology---Platelets
Time Frame
2 to 5 days after last dose
Title
Safety---Clinical Chemistry Variables Over Time---Glucose
Description
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Clinical Chemistry---Glucose
Time Frame
2 to 5 days after last dose
Title
Safety---Clinical Chemistry Variables Over Time---Alanine Aminotransferase
Description
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Clinical Chemistry---Alanine Aminotransferase
Time Frame
2 to 5 days after last dose
Title
Safety---Clinical Chemistry Variables Over Time---Aspartate Aminotransferase
Description
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Clinical Chemistry---Aspartate Aminotransferase
Time Frame
2 to 5 days after last dose
Title
Safety---Clinical Chemistry Variables Over Time---Alkaline Phosphatase
Description
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Clinical Chemistry---Alkaline Phosphatase
Time Frame
2 to 5 days after last dose
Title
Safety---Clinical Chemistry Variables Over Time---Creatinine
Description
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Clinical Chemistry---Creatinine
Time Frame
2 to 5 days after last dose
Title
Safety---Clinical Chemistry Variables Over Time---Total Bilirubin
Description
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Clinical Chemistry---Total Bilirubin
Time Frame
2 to 5 days after last dose
Title
Safety---Clinical Chemistry Variables Over Time---Sodium
Description
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Clinical Chemistry---Sodium
Time Frame
2 to 5 days after last dose
Title
Safety---Clinical Chemistry Variables Over Time---Potassium
Description
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Clinical Chemistry---Potassium
Time Frame
2 to 5 days after last dose
Title
Safety---Clinical Chemistry Variables Over Time---Chloride
Description
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Clinical Chemistry---Chloride
Time Frame
2 to 5 days after last dose
Title
Safety---Clinical Chemistry Variables Over Time---Phosphate
Description
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Clinical Chemistry---Phosphate
Time Frame
2 to 5 days after last dose
Title
Safety---Clinical Chemistry Variables Over Time---Albumin
Description
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Clinical Chemistry---Albumin
Time Frame
2 to 5 days after last dose
Title
Safety---Clinical Chemistry Variables Over Time---Protein
Description
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Clinical Chemistry---Protein
Time Frame
2 to 5 days after last dose
Title
Safety---Clinical Chemistry Variables Over Time---Blood Urea Nitrogen
Description
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Clinical Chemistry---Blood Urea Nitrogen
Time Frame
2 to 5 days after last dose
Title
Safety---Clinical Chemistry Variables Over Time---Bicarbonate
Description
The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.
Safety will be assessed by:
• Clinical Chemistry---Bicarbonate
Time Frame
2 to 5 days after last dose
Title
Pharmacokinetics Parameters of Metabolite : Parent on Day 1--AUC(0-inf)
Description
To determine AUC(0-inf) ratio for the metabolite to that of the parent compound on Day 1
Time Frame
Day 1
Title
Pharmacokinetics Parameters of Metabolite : Parent on Day 7---AUC(0-12h)
Description
To determine AUC(0-12h) ratio of metabolite to that of the parent compound on Day 7.
Time Frame
Day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provision of signed and dated written informed consent prior to any study specific procedures.
Female or male Chinese (as defined by Chinese Regulatory) patients aged 18 years or older with suitable veins for cannulations or repeated venipunctures.
Documented stable coronary heart disease (CHD) fulfilling all of the following, and taking 75-100 mg ASA daily treatment:
Diagnosed stable angina pectoris per the guidance of Chinese Society of Cardiology published in 2007, patients with angina severity classified as I and II of Canadian Cardiovascular Society grading of angina pectoris.
Female patients without pregnant potential
Exclusion Criteria:
Any indication for oral anticoagulant or dual antiplatelet treatment and chronic ASA with doses greater than 100 mg/day.
Concomitant therapy with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic index, or strong CYP3A inducers within 14 days preceding the first dose of study medication and during study treatment.
Increased bleeding risk.
Contraindication or other reason that ASA or ticagrelor should not be administered
Patients that are scheduled for revascularization (eg, PCI, CABG) during the study period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haiyan Li, PhD
Organizational Affiliation
The 3rd Hospital of Peking University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Beijing
Country
China
12. IPD Sharing Statement
Learn more about this trial
Ticagrelor China Pharmacokinetic/Pharmacodynamic Study
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