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

NCT01775839 | Completed Phase 4 DMC

• 1 other identifier: PGX_Clopidogrel_002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

DRUG REACTIONS

Outcome Measures

Primary Outcomes (1)

• 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

  pre- and post dose of Clopidogrel, Digoxin administration

Study Arms (2)

Aspirin+Clopidogrel/Digoxin(oral)

EXPERIMENTAL

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

Drug: Aspirin+Clopidogrel/Digoxin(oral)

Aspirin+Clopidogrel/Digoxin(IV)

EXPERIMENTAL

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

Drug: Aspirin+Clopidogrel/Digoxin(IV)

Interventions

Aspirin+Clopidogrel/Digoxin(oral) DRUG

oral administration of digoxin

Also known as: Aspirin, Clopidogrel, Digoxin

Aspirin+Clopidogrel/Digoxin(oral)

Aspirin+Clopidogrel/Digoxin(IV) DRUG

intravenous administration of digoxin

Also known as: Aspirin, Clopidogrel, Digoxin

Aspirin+Clopidogrel/Digoxin(IV)

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital Clinical Trials Center

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Interventions

Aspirin; Clopidogrel; Digoxin

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates

Study Officials

• In-Jin Jang, MD

  SNUH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2013
• First Posted: January 25, 2013
• Study Start: January 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: June 10, 2014

Record last verified: 2014-06

Locations

KR (1)