Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| H7T-FW-TACQ | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to investigate how the body processes prasugrel and how prasugrel affects blood clotting in healthy Korean men. Three different dosing regimens of prasugrel will be given. Information on side effects will also be collected.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prasugrel - 60 mg/10 mg | Experimental | Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days |
|
| Prasugrel - 30 mg/7.5 mg | Experimental | Prasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days |
|
| Prasugrel - 30 mg/5 mg | Experimental | Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prasugrel | Drug | Tablets orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Prasugrel's Active Metabolite R-138727 During Loading Dose | AUC from time zero to the last quantifiable plasma concentration (tlast) | Day 1 predose up to 24 hours post dose |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) for Prasugrel's Active Metabolite R-138727 During Loading Dose | Day 1 predose up to 24 hours post dose | |
| Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of Prasugrel's Active Metabolite R-138727 During Loading Dose | Day 1 predose up to 24 hours post dose | |
| Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Prasugrel's Active Metabolite R-138727 During Maintenance Dose | AUC from time zero to the last quantifiable plasma concentration (tlast) | Day 11 predose to 24 hours post dose |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) for Prasugrel's Active Metabolite R-138727 During Maintenance Dose | Day 11 predose to 24 hours post dose | |
| Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of Prasugrel's Active Metabolite R-138727 During Maintenance Dose | Day 11 predose to 24 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics: Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation | ADP-induced PRU represents the rate and extent of ADP-stimulated platelet aggregation and serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition | Predose up to 24 hours post dose on Day 12 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23594968 | Derived | Yu KS, Park KW, Kelly RP, Gu N, Payne C, Small DS, Choi HC, Kawakatsu E, Pinton P. Pharmacokinetic and pharmacodynamic effects of prasugrel in healthy Korean males. J Cardiovasc Pharmacol. 2013 Jul;62(1):72-7. doi: 10.1097/FJC.0b013e318290d9e1. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Prasugrel - 60 mg/10 mg | Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days |
| FG001 | Prasugrel - 30 mg/7.5 mg | Prasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days |
| FG002 | Prasugrel - 30 mg/5 mg | Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Prasugrel - 60 mg/10 mg | Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days |
| BG001 | Prasugrel - 30 mg/7.5 mg | Prasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Prasugrel's Active Metabolite R-138727 During Loading Dose | AUC from time zero to the last quantifiable plasma concentration (tlast) | All randomized participants | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram times hour/milliliter (ng*h/mL) | Day 1 predose up to 24 hours post dose |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prasugrel - 60 mg/10 mg | Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest discomfort | General disorders | MedDRA 11.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D000068799 | Prasugrel Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D010879 | Piperazines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Percent Inhibition of Verify Now (VN)-P2Y12 Reaction Units (PRU) |
PRU device reported VerifyNow percent inhibition is reported by Accumetrics VerifyNow™ P2Y12 (VN-P2Y12) assay, a point-of-care device that measures platelet aggregation with single-use, disposable cartridges |
| Predose up to 24 hours post dose on Day 12 |
| BG002 | Prasugrel - 30 mg/5 mg | Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Pharmacokinetics (PK): Maximum Concentration (Cmax) for Prasugrel's Active Metabolite R-138727 During Loading Dose | All randomized participants | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram/milliliter (ng/mL) | Day 1 predose up to 24 hours post dose |
|
|
|
| Primary | Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of Prasugrel's Active Metabolite R-138727 During Loading Dose | All randomized participants | Posted | Median | Full Range | hours | Day 1 predose up to 24 hours post dose |
|
|
|
| Secondary | Pharmacodynamics: Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation | ADP-induced PRU represents the rate and extent of ADP-stimulated platelet aggregation and serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition | All randomized participants | Posted | Mean | Standard Deviation | PRU | Predose up to 24 hours post dose on Day 12 |
|
|
|
| Primary | Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Prasugrel's Active Metabolite R-138727 During Maintenance Dose | AUC from time zero to the last quantifiable plasma concentration (tlast) | All randomized participants | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Day 11 predose to 24 hours post dose |
|
|
|
| Primary | Pharmacokinetics (PK): Maximum Concentration (Cmax) for Prasugrel's Active Metabolite R-138727 During Maintenance Dose | All randomized participants | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 11 predose to 24 hours post dose |
|
|
|
| Primary | Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of Prasugrel's Active Metabolite R-138727 During Maintenance Dose | All randomized participants | Posted | Median | Full Range | hours | Day 11 predose to 24 hours post dose |
|
|
|
| Secondary | Percent Inhibition of Verify Now (VN)-P2Y12 Reaction Units (PRU) | PRU device reported VerifyNow percent inhibition is reported by Accumetrics VerifyNow™ P2Y12 (VN-P2Y12) assay, a point-of-care device that measures platelet aggregation with single-use, disposable cartridges | All randomized participants | Posted | Mean | Standard Deviation | Percent inhibition of PRU | Predose up to 24 hours post dose on Day 12 |
|
|
|
| 0 |
| 10 |
| 3 |
| 10 |
| EG001 | Prasugrel - 30 mg/7.5 mg | Prasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days | 0 | 10 | 4 | 10 |
| EG002 | Prasugrel - 30 mg/5 mg | Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days | 0 | 10 | 3 | 10 |
| Vessel puncture site paraesthesia | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Sputum retention | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
Not provided
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
|
| Day 1, 1 hour |
|
| Day1, 2 hours |
|
| Day 1, 4 hours |
|
| Day 1, 24 hours |
|
| Day 10, predose |
|
| Day 11, predose |
|
| Day 11, 24 hours |
|
|
| Day 1, 1 hour |
|
| Day1, 2 hours |
|
| Day 1, 4 hours |
|
| Day 1, 24 hours |
|
| Day 10, predose |
|
| Day 11, predose |
|
| Day 11, 24 hours |
|