Clinical trial NCT01591317: Study of Prasugrel in Korean Healthy Male Volunteers
Official title: Single and Multiple Dose Pharmacokinetics and Pharmacodynamics of Prasugrel (LY640315) in Korean Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2012-05-04
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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* Are persons who have previously completed or withdrawn from this study or any other study investigating prasugrel.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

Primary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Prasugrel's Active Metabolite R-138727 During Loading Dose
timeFrame: Day 1 predose up to 24 hours post dose
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) for Prasugrel's Active Metabolite R-138727 During Loading Dose
timeFrame: Day 1 predose up to 24 hours post dose
measure: Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of Prasugrel's Active Metabolite R-138727 During Loading Dose
timeFrame: Day 1 predose up to 24 hours post dose
measure: Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Prasugrel's Active Metabolite R-138727 During Maintenance Dose
timeFrame: Day 11 predose to 24 hours post dose
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) for Prasugrel's Active Metabolite R-138727 During Maintenance Dose
timeFrame: Day 11 predose to 24 hours post dose
measure: Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of Prasugrel's Active Metabolite R-138727 During Maintenance Dose
timeFrame: Day 11 predose to 24 hours post dose
Secondary outcomes:
measure: Pharmacodynamics: Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation
timeFrame: Predose up to 24 hours post dose on Day 12
measure: Percent Inhibition of Verify Now (VN)-P2Y12 Reaction Units (PRU)
timeFrame: Predose up to 24 hours post dose on Day 12
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: 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.