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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01775839
First received: January 15, 2013
Last updated: June 8, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
DRUG REACTIONS
Drug: Aspirin+Clopidogrel/Digoxin(oral)
Drug: Aspirin+Clopidogrel/Digoxin(IV)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • AUC and Cmax of Clopidogrel and Digoxin [ Time Frame: pre- and post dose of Clopidogrel, Digoxin administration ] [ Designated as safety issue: No ]
    (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


Enrollment: 24
Study Start Date: January 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01775839

Locations
Korea, Republic of
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
  More Information

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01775839     History of Changes
Other Study ID Numbers: PGX_Clopidogrel_002
Study First Received: January 15, 2013
Last Updated: June 8, 2014
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Aspirin
Clopidogrel
Digoxin
Ticlopidine
Analgesics
Analgesics, Non-Narcotic
Anti-Arrhythmia Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Cardiotonic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Protective Agents
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists

ClinicalTrials.gov processed this record on October 21, 2014