Study of Prasugrel in Korean Healthy Male Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01591317
First received: May 2, 2012
Last updated: September 4, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Drug: Prasugrel
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single and Multiple Dose Pharmacokinetics and Pharmacodynamics of Prasugrel (LY640315) in Korean Healthy Male Subjects

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Prasugrel's Active Metabolite R-138727 During Loading Dose [ Time Frame: Day 1 predose up to 24 hours post dose ] [ Designated as safety issue: No ]
    AUC from time zero to the last quantifiable plasma concentration (tlast)

  • Pharmacokinetics (PK): Maximum Concentration (Cmax) for Prasugrel's Active Metabolite R-138727 During Loading Dose [ Time Frame: Day 1 predose up to 24 hours post dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of Prasugrel's Active Metabolite R-138727 During Loading Dose [ Time Frame: Day 1 predose up to 24 hours post dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Prasugrel's Active Metabolite R-138727 During Maintenance Dose [ Time Frame: Day 11 predose to 24 hours post dose ] [ Designated as safety issue: No ]
    AUC from time zero to the last quantifiable plasma concentration (tlast)

  • Pharmacokinetics (PK): Maximum Concentration (Cmax) for Prasugrel's Active Metabolite R-138727 During Maintenance Dose [ Time Frame: Day 11 predose to 24 hours post dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of Prasugrel's Active Metabolite R-138727 During Maintenance Dose [ Time Frame: Day 11 predose to 24 hours post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacodynamics: Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation [ Time Frame: Predose up to 24 hours post dose on Day 12 ] [ Designated as safety issue: No ]
    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

  • Percent Inhibition of Verify Now (VN)-P2Y12 Reaction Units (PRU) [ Time Frame: Predose up to 24 hours post dose on Day 12 ] [ Designated as safety issue: No ]
    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


Enrollment: 30
Study Start Date: March 2009
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prasugrel - 60 mg/10 mg
Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days
Drug: Prasugrel
Tablets orally
Other Names:
  • LY640315
  • Effient
  • Efient
  • Prasita
Experimental: 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
Drug: Prasugrel
Tablets orally
Other Names:
  • LY640315
  • Effient
  • Efient
  • Prasita
Experimental: Prasugrel - 30 mg/5 mg
Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
Drug: Prasugrel
Tablets orally
Other Names:
  • LY640315
  • Effient
  • Efient
  • Prasita

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01591317

Locations
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, Korea, Republic of
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
  More Information

No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01591317     History of Changes
Other Study ID Numbers: 11990, H7T-FW-TACQ
Study First Received: May 2, 2012
Results First Received: September 4, 2012
Last Updated: September 4, 2012
Health Authority: Korea: Ministry for Health, Welfare and Family Affairs

Additional relevant MeSH terms:
Prasugrel
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists

ClinicalTrials.gov processed this record on October 29, 2014