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

DRUG REACTIONS Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01775839
• Other study ID #: PGX_Clopidogrel_002
• Status: Completed
• Phase: Phase 4
• First received: January 15, 2013
• Last updated: June 8, 2014
• Start date: January 2013
• Est. completion date: April 2014

Study information

• Verified date: June 2014
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• DRUG REACTIONS
• Drug-Related Side Effects and Adverse Reactions

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital Clinical Trials Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No