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

NCT02075268 | Unknown Phase 1

• 2 other identifiers: PRAS-AM2014-0064
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Keywords

Korean; Healthy; Male

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

10 mg, 30 mg

OTHER

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

Interventions

prasugrel DRUG

prausugrel 10 or 30 mg will be administrated as single dose under overnight fast.

Also known as: Effient 10 mg tablet will be used as study drug.

10 mg, 30 mg

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, Seoul, 138-736, South Korea

RECRUITING

Related Publications (1)

• Jeon HS, Kim MJ, Choi HY, Kim YH, Kim EH, Kim AR, Park HJ, Bae KS, Lim HS. Pharmacokinetics and pharmacodynamics of ticagrelor and prasugrel in healthy male Korean volunteers. Clin Ther. 2015 Mar 1;37(3):563-73. doi: 10.1016/j.clinthera.2015.01.010. Epub 2015 Feb 16.

  PMID: 25697420 DERIVED

MeSH Terms

Interventions

Prasugrel Hydrochloride; Drug Evaluation

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Development; Investigative Techniques; Evaluation Studies as Topic

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 27, 2014
• First Posted: March 3, 2014
• Study Start: January 1, 2014
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: March 4, 2014

Record last verified: 2014-02

Locations

KR (1)