Study of Prasugrel in Korean Healthy Male Volunteers

Healthy Volunteers Clinical Trial

Official title:

Single and Multiple Dose Pharmacokinetics and Pharmacodynamics of Prasugrel (LY640315) in Korean Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01591317
• Other study ID #: 11990
• Secondary ID: H7T-FW-TACQ
• Status: Completed
• Phase: Phase 1
• First received: May 2, 2012
• Last updated: September 4, 2012
• Start date: March 2009
• Est. completion date: May 2009

Study information

• Verified date: September 2012
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Are overtly healthy males, as determined by medical history and physical examination.

• Are between the ages of 20 and 45 years, inclusive.

• Have a body mass index (BMI) of 19 kg/m^2 to 27 kg/m^2, inclusive, at screening.

Exclusion Criteria:

• Are currently enrolled in, or discontinued within the last 60 days from a clinical trial involving an investigational drug or device, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.

• Have known allergies to prasugrel or related compounds.

• Are persons who have previously completed or withdrawn from this study or any other study investigating prasugrel.

• Self-reported history of significant bleeding from trauma (for example, prolonged bleeding after tooth extraction).

• History of major surgery within 3 months of screening or planned surgery within 14 days after the last day of dosing.

• Have a platelet count of <100,000/(cubic millimeters) mm^3 at the time of screening.

• Have tested positive for fecal occult blood at screening.

• Have significant prolongation of prothrombin time (PT) or activated partial thromboplastin time (APTT) at screening.

• Have a clinically significant abnormality following the investigator's review of the physical examination, electrocardiogram (ECG)and clinical (safety) laboratory tests at screening.

• Personal or first-degree family history of coagulation or bleeding disorders (that is, hematemesis, melena, severe or recurrent epistaxis, hemoptysis, gastrointestinal ulcers, hemorrhage, clinically overt hematuria or intracranial hemorrhage) or reasonable suspicion of vascular malformations, for example, cerebral hemorrhage, aneurysm or premature stroke (cerebrovascular accident [CVA] <65 years of age).

• Have significant active hematological disease and/or whole blood donation of more than 400 mL within the last 2 months and component blood donation within the last month.

• Volunteers who have an average weekly alcohol intake that exceeds 21 units per week or volunteers unwilling to adhere to study alcohol restrictions during the study (1 unit = 360 mL of beer; 150 mL of wine; 45 mL of distilled spirits).

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Prasugrel
Tablets orally

Locations

Country	Name	City	State
Korea, Republic of	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	Day 1 predose up to 24 hours post dose	No
Primary	Pharmacokinetics (PK): Maximum Concentration (Cmax) for Prasugrel's Active Metabolite R-138727 During Loading Dose		Day 1 predose up to 24 hours post dose	No
Primary	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	No
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)	Day 11 predose to 24 hours post dose	No
Primary	Pharmacokinetics (PK): Maximum Concentration (Cmax) for Prasugrel's Active Metabolite R-138727 During Maintenance Dose		Day 11 predose to 24 hours post dose	No
Primary	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	No
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	Predose up to 24 hours post dose on Day 12	No
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	Predose up to 24 hours post dose on Day 12	No