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Study of Prasugrel in Korean Healthy Male Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01591317
Recruitment Status : Completed
First Posted : May 4, 2012
Results First Posted : October 4, 2012
Last Update Posted : October 4, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Prasugrel Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single and Multiple Dose Pharmacokinetics and Pharmacodynamics of Prasugrel (LY640315) in Korean Healthy Male Subjects
Study Start Date : March 2009
Primary Completion Date : May 2009
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Prasugrel
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
    AUC from time zero to the last quantifiable plasma concentration (tlast)

  2. 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 ]
  3. 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 ]
  4. 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 ]
    AUC from time zero to the last quantifiable plasma concentration (tlast)

  5. 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 ]
  6. 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 ]

Secondary Outcome Measures :
  1. Pharmacodynamics: Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation [ Time Frame: Predose up to 24 hours post dose on Day 12 ]
    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

  2. Percent Inhibition of Verify Now (VN)-P2Y12 Reaction Units (PRU) [ Time Frame: Predose up to 24 hours post dose on Day 12 ]
    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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( Other Identifier: Eli Lilly and Company )
First Posted: May 4, 2012    Key Record Dates
Results First Posted: October 4, 2012
Last Update Posted: October 4, 2012
Last Verified: September 2012

Additional relevant MeSH terms:
Prasugrel Hydrochloride
Platelet Aggregation Inhibitors