Clinical Trial to Characterize Pharmacokinetic-pharmacodynamic (PKPD) of Prasugrel 10 mg or 30 mg in Healthy Volunteers (PRAS-AM)

February 28, 2014 updated by: Hyeong-Seok Lim, Asan Medical Center

An Open Label, Single Dose Study to Characterize the Pharmacokinetics and Pharmacodynamics of Prasugrel in Healthy Male Adult Subjects

An open label, parallel study to characterize the pharmacokinetics and pharmacodynamics of Prasugrel 30 mg or 60 mg in healthy male adult subjects

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

  1. Screening
  2. Enrollment and treatment randomization
  3. Confinement to Research Unit from day - 1 to day 2
  4. Outpatient visit : 2 times ( 48 and 73 hours after dosing)
  5. Drug administration : Overnight Fasting

  6. Blood sampling for PK, PD and genotyping

    1. PK: up to 24 hours after dosing
    2. PD: up to 72 hours after dosing

Study Type

Interventional

Enrollment (Anticipated)

8

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 138-736
        • Recruiting
        • Asan Medical Center
        • Contact:
        • Principal Investigator:
          • Hyeong-Suk Lim, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • male aged 19 to 45 years
  • weigh over 60 kg
  • body mass index 18 to 30 kg/m2

Exclusion Criteria:

  • any history or state of clinically significant disease
  • any gastrointestinal disease may interfere absorption of drug
  • any history of hypersensitivity to prasugrel or other drug
  • any history of taking herbal medication within 30 days before dosing or taking prescription medication within 14 days before dosing or taking over the counter drug within 7 days before dosing
  • taking investigational drug within 60 days before dosing
  • transfused within 30 days or donated blood within 60 days before dosing
  • Positive serology test ( Hepatitis B surface antigen (HBs Ag), HIV, HCV)
  • Clinically significant finding in laboratory result or electrocardiogram result

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 10 mg, 30 mg
To compare PKPD of prasugrel 10 or 30 mg, 4 subjects will be given 10 mg of prasugrel (one tablet of 10 mg of Effient) on day 1 as a single oral dose and another 4 subjects will be given 30 mg of prasugrel (3 tablets of 10 mg of Effient) on day 1 as a single oral dose.
Drug: prasugrel
prausugrel 10 or 30 mg will be administrated as single dose under overnight fast.
Other Names:
  • Effient 10 mg tablet will be used as study drug.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
plasma R-138727 and R-95913 concentrations
Time Frame: predose, 10 min, 15 min, 25 min, 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 4 h, 6 h, 8 h, 12 h and 24 h after dosing
predose, 10 min, 15 min, 25 min, 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 4 h, 6 h, 8 h, 12 h and 24 h after dosing

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal platelet aggregation
Time Frame: predose, 15 min, 0.5 h, 1 h, 2 h, 4 h, 8 h, 24 h, 48 h and 72 h after dosing
Maximal platelet aggregation will be measured by light transmission test
predose, 15 min, 0.5 h, 1 h, 2 h, 4 h, 8 h, 24 h, 48 h and 72 h after dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

February 1, 2014

Study Completion (Anticipated)

February 1, 2014

Study Registration Dates

First Submitted

February 27, 2014

First Submitted That Met QC Criteria

February 27, 2014

First Posted (Estimate)

March 3, 2014

Study Record Updates

Last Update Posted (Estimate)

March 4, 2014

Last Update Submitted That Met QC Criteria

February 28, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRAS-AM
  • 2014-0064 (Other Identifier: Institutional review board of Asan Medical Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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