Cytochrome P450 2D6 Genotype on the Clinical Effect of Carvedilol

Seoul National University

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Carvedilol; Other: Isoproterenol Sensitivity Test

Study type: Interventional

Funder types: Other

Identifiers

NCT02286934

CYP-CVDL-01

Details and patient eligibility

About

A Clinical Study to Evaluate the Effect of Cytochrome P450 2D6 polymorphism on Pharmacokinetics/Pharmacodynamics After Multiple Administration of Carvedilol

Full description

This study has an open-label, one-sequence, multiple drug administration design. The purpose of this study is as follows;

To evaluate the change of the result of Isoproterenol Sensitivity Test according to Cytochrome P450 2D6 genotype after the multiple administration of carvedilol

Enrollment: 24 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy Subjects aged 20 - 45 years
• A body mass index (BMI) in the range 18.0 kg/m2 (inclusive) - 27.0 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 (Carvedilol, Isoproterenol).
• Subject judged not eligible for study participation by investigator.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Carvedilol

Experimental group

Description:

* Day 1 to 3 : Carvedilol 12.5 mg qd * Day 4 to 8 : Carvedilol 25 mg qd * Day 9 to 11 : Carvedilol 12.5 mg qd Isoproterenol Sensitivity Test * Day 0, 1.5h post-dose Injection of isoproterenol 4 times (0.25, 0.5, 1, 2 ug/mL), time interval of 10 minutes. * Day 1, 8, 1.5h post-dose Injection of isoproterenol 4 times (5, 10, 20, 40 ug/mL), time interval of 10 minutes. Measure change of heart rates after 1, 2, 3 minutes post injection of isoproterenol.

Treatment:

Drug: Carvedilol

Other: Isoproterenol Sensitivity Test