Study of Prasugrel in Korean Healthy Male Volunteers

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01591317

Enrollment

Registered

2012-05-04

Start date

2009-03-31

Completion date

2009-05-31

Last updated

2012-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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.

Interventions

DRUGPrasugrel

Tablets orally

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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 * Are persons who have previously completed or withdrawn from this study or any other study investigating prasugrel.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

Design outcomes

Primary

Measure	Time frame	Description
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	—
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	—
Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Prasugrel's Active Metabolite R-138727 During Maintenance Dose	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	Day 11 predose to 24 hours post dose	—
Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Prasugrel's Active Metabolite R-138727 During Loading Dose	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	Day 1 predose up to 24 hours post dose	—

Secondary

Measure	Time frame	Description
Percent Inhibition of Verify Now (VN)-P2Y12 Reaction Units (PRU)	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
Pharmacodynamics: Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation	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

Countries

South Korea

Participant flow

Participants by arm

Arm	Count
Prasugrel - 60 mg/10 mg Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days	10
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	10
Prasugrel - 30 mg/5 mg Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days	10
Total	30

Baseline characteristics

Characteristic	Prasugrel - 60 mg/10 mg	Prasugrel - 30 mg/7.5 mg	Prasugrel - 30 mg/5 mg	Total
Age Continuous	28.2 years STANDARD_DEVIATION 5.3	25.9 years STANDARD_DEVIATION 5.2	26.0 years STANDARD_DEVIATION 4.1	26.7 years STANDARD_DEVIATION 4.9
Race/Ethnicity, Customized Asian	10 participants	10 participants	10 participants	30 participants
Region of Enrollment Korea, Republic of	10 participants	10 participants	10 participants	30 participants
Sex: Female, Male Female	0 Participants	0 Participants	0 Participants	0 Participants
Sex: Female, Male Male	10 Participants	10 Participants	10 Participants	30 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	3 / 10	4 / 10	3 / 10
serious Total, serious adverse events	0 / 10	0 / 10	0 / 10

Outcome results

Primary