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

Phase 1

• Conditions: Healthy
• Interventions: Drug: prasugrel

• Registration Number: NCT02075268
• Lead Sponsor: Asan Medical Center

Brief Summary

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

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 Timeline

• Study Start: 2014-01
• Status Verified: 2014-02
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Study First Submitted: 2014-02-27
• Study First Submitted QC: 2014-02-27
• Last Update Submitted: 2014-02-28
• Study First Posted: 2014-03-03
• Last Update Posted: 2014-03-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
10 mg, 30 mg	prasugrel	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.

Primary Outcome Measures

Name	Time	Method
plasma R-138727 and R-95913 concentrations	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

Name	Time	Method
Maximal platelet aggregation	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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of