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

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2014

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

Interventions

  • Drug: prasugrel
    • prausugrel 10 or 30 mg will be administrated as single dose under overnight fast.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 19 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Asan Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hyeong-Seok Lim, Associate Professor – Asan Medical Center

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