NCT01591317

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Mar 2009

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 4, 2012

Completed
5 months until next milestone

Results Posted

Study results publicly available

October 4, 2012

Completed
Last Updated

October 4, 2012

Status Verified

September 1, 2012

Enrollment Period

2 months

First QC Date

May 2, 2012

Results QC Date

September 4, 2012

Last Update Submit

September 4, 2012

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (6)

  • Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Prasugrel's Active Metabolite R-138727 During Loading Dose

    AUC from time zero to the last quantifiable plasma concentration (tlast)

    Day 1 predose up to 24 hours post dose

  • Pharmacokinetics (PK): Maximum Concentration (Cmax) for Prasugrel's Active Metabolite R-138727 During Loading Dose

    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

    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

    AUC from time zero to the last quantifiable plasma concentration (tlast)

    Day 11 predose to 24 hours post dose

  • 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): Time to Maximum Concentration (Tmax) of Prasugrel's Active Metabolite R-138727 During Maintenance Dose

    Day 11 predose to 24 hours post dose

Secondary Outcomes (2)

  • Pharmacodynamics: Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation

    Predose up to 24 hours post dose on Day 12

  • Percent Inhibition of Verify Now (VN)-P2Y12 Reaction Units (PRU)

    Predose up to 24 hours post dose on Day 12

Study Arms (3)

Prasugrel - 60 mg/10 mg

EXPERIMENTAL

Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days

Drug: Prasugrel

Prasugrel - 30 mg/7.5 mg

EXPERIMENTAL

Prasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days

Drug: Prasugrel

Prasugrel - 30 mg/5 mg

EXPERIMENTAL

Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days

Drug: Prasugrel

Interventions

PrasugrelDRUG

Tablets orally

Also known as: LY640315, Effient, Efient, Prasita
Prasugrel - 30 mg/5 mgPrasugrel - 30 mg/7.5 mgPrasugrel - 60 mg/10 mg

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 23594968DERIVED

MeSH Terms

Interventions

Prasugrel Hydrochloride

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2012

First Posted

May 4, 2012

Study Start

March 1, 2009

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

October 4, 2012

Results First Posted

October 4, 2012

Record last verified: 2012-09

Locations

KR(1)