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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):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE May 2, 2012
First Posted Date  ICMJE May 4, 2012
Results First Submitted Date  ICMJE September 4, 2012
Results First Posted Date  ICMJE October 4, 2012
Last Update Posted Date October 4, 2012
Study Start Date  ICMJE March 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2012)
  • 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)
  • 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 ]
  • 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 ]
  • 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)
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 2, 2012)
  • Pharmacokinetics (PK): Area under the concentration curve (AUC) of prasugrel's active metabolite R-138727 [ Time Frame: Day 1 at 0.25 hours up to 24 hours post dose on Day 12 ]
  • Pharmacokinetics (PK): Maximum concentration (Cmax) for prasugrel's active metabolite R-138727 [ Time Frame: Day 1 at 0.25 hours up to 24 hours post dose on Day 12 ]
  • Pharmacokinetics (PK): Time to maximum concentration (Tmax) of prasugrel's active metabolite R-138727 [ Time Frame: Day 1 at 0.25 hours up to 24 hours post dose on Day 12 ]
Change History Complete list of historical versions of study NCT01591317 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2012)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2012)
Pharmacodynamics: Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation [ Time Frame: Predose up to 24 hours post dose on Day 12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Prasugrel in Korean Healthy Male Volunteers
Official Title  ICMJE Single and Multiple Dose Pharmacokinetics and Pharmacodynamics of Prasugrel (LY640315) in Korean Healthy Male Subjects
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE Drug: Prasugrel
Tablets orally
Other Names:
  • LY640315
  • Effient
  • Efient
  • Prasita
Study Arms  ICMJE
  • 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
    Intervention: Drug: Prasugrel
  • 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
    Intervention: Drug: Prasugrel
  • 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
    Intervention: Drug: Prasugrel
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 2, 2012)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01591317
Other Study ID Numbers  ICMJE 11990
H7T-FW-TACQ ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP