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Clinical Trial to Evaluate the Influence of Genotype and DDIs of Aspirin on the PK/PD of Clopidogrel and PK of Digoxin

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01775839
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
14.9
Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Clinical trial to evaluate the influence of multiple aspirin administration on PK and PD of co-administered drugs

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Clinical trial to evaluate the influence of genotype of drug metabolizing enzyme or transporter and drug-drug interactions of aspirin co-administration on the pharmacokinetics / pharmacodynamics of clopidogrel and pharmacokinetics of digoxin in healthy volunteers

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Clinical Trial to Evaluate the Influence of Genotype of Drug Metabolizing Enzyme or Transporter and Drug-drug Interactions of Aspirin Co-administration on the PK/PD of Clopidogrel and PK of Digoxin in Healthy Volunteers
Study Start Date :
Jan 1, 2013
Actual Primary Completion Date :
Apr 1, 2014
Actual Study Completion Date :
Apr 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Aspirin+Clopidogrel/Digoxin(oral)

Aspirin: Day 1 ~ Day 59(~65; till the EGC) Clopidogrel: Day -3, 26, 54 Digoxin: Day -2, 27, 55

Drug: Aspirin+Clopidogrel/Digoxin(oral)
oral administration of digoxin
Other Names:
  • Aspirin
  • Clopidogrel
  • Digoxin

    		•
    Experimental: Aspirin+Clopidogrel/Digoxin(IV)

    Aspirin: Day 1 ~ Day 59(~65; till the EGC) Clopidogrel: Day -3, 26, 54 Digoxin: Day -2, 27, 55

    Drug: Aspirin+Clopidogrel/Digoxin(IV)
    intravenous administration of digoxin
    Other Names:
  • Aspirin
  • Clopidogrel
  • Digoxin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. AUC and Cmax of Clopidogrel and Digoxin [pre- and post dose of Clopidogrel, Digoxin administration]

      (Clopidogrel)Predose and 10, 20, 30, 40, 50 min, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 h postdose on Week 0, 4, 8 (Digoxin) Predose and 10, 20, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 h postdose on Week 0, 4, 8

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 45 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Healthy male subjects aged 20 - 45 years.

    • A body weight in the range of 50 kg (inclusive) - 90 kg (exclusive) and a body mass index (BMI) in the range 18.5 kg/m2 (inclusive) - 27 kg/m2 (inclusive).

    • Sufficient ability to understand the nature of the study and any hazards of participating in it. Provide written informed consent after being fully. informed about the study procedures.

    Exclusion Criteria:

    • Presence or history of hypersensitivity or allergic reactions to drugs including investigational product (clopidogrel, digoxin or aspirin)

    • Clinically relevant abnormal medical history that could interfere with the objectives of the study.

    • A subject with history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug.

    • A subject whose lab test results are as follows; Platelet count or PT, aPTT < 0.9 x lower limit of reference range of > 1.1 x upper limit of reference range.

    • A subject whose SBP is over 160 mmHg or below 90 mmHg and DBP is over 100 mmHg or below 50 mmHg.

    • Clinically significant abnormal findings of ECG during screening test.

    • Presence or history of drug abuse or positive result in urine drug screening test.

    • Participation in other clinical trial within 2 months before first dose.

    • Use of CYP inducer (ex. rifampin) within 4 weeks before first dose.

    • Use of a prescription medicine, herbal medicine within 2 weeks or over-the-counter medication or vitamin substances within 1 week before first dose.

    • Use of grapefruit juice within 1 week before first dose.

    • Blood donation during 2 months or apheresis during 1 month before the study.

    • Use of alcohol over 21 units/weeks

    • Smoking of more than 10 cigarettes/days within 3 months before first dose.

    • Subject judged not eligible for study participation by investigator.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital Clinical Trials Center Seoul Korea, Republic of 110-744

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    • Principal Investigator: In-Jin Jang, MD, SNUH

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT01775839
    Other Study ID Numbers:
    • PGX_Clopidogrel_002
    First Posted:
    Jan 25, 2013
    Last Update Posted:
    Jun 10, 2014
    Last Verified:
    Jun 1, 2014
    Additional relevant MeSH terms:
    Drug-Related Side Effects and Adverse Reactions
    Aspirin
    Digoxin
    Clopidogrel

    Study Results

    No Results Posted as of Jun 10, 2014