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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

Primary Purpose

DRUG REACTIONS

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Aspirin+Clopidogrel/Digoxin(oral)

Aspirin+Clopidogrel/Digoxin(IV)

About this trial

This is an interventional basic science trial for DRUG REACTIONS

Eligibility Criteria

20 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

Seoul National University Hospital Clinical Trials Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Aspirin+Clopidogrel/Digoxin(oral)

Aspirin+Clopidogrel/Digoxin(IV)

Arm Description

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

Outcomes

Primary Outcome Measures

AUC and Cmax of Clopidogrel and Digoxin

(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

Secondary Outcome Measures

Full Information

NCT ID

NCT01775839

First Posted

January 15, 2013

Last Updated

June 8, 2014

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01775839

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

DRUG REACTIONS

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aspirin+Clopidogrel/Digoxin(oral)

Arm Type

Experimental

Arm Description

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

Arm Title

Aspirin+Clopidogrel/Digoxin(IV)

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Aspirin+Clopidogrel/Digoxin(oral)

Other Intervention Name(s)

Aspirin, Clopidogrel, Digoxin

Intervention Description

oral administration of digoxin

Intervention Type

Drug

Intervention Name(s)

Aspirin+Clopidogrel/Digoxin(IV)

Other Intervention Name(s)

Aspirin, Clopidogrel, Digoxin

Intervention Description

intravenous administration of digoxin

Primary Outcome Measure Information:

Title

AUC and Cmax of Clopidogrel and Digoxin

Description

Time Frame

pre- and post dose of Clopidogrel, Digoxin administration

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

In-Jin Jang, MD

Organizational Affiliation

SNUH

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Hospital Clinical Trials Center

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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