Cytochrome P450 2D6 Genotype on the Clinical Effect of Carvedilol

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Carvedilol; Other: Isoproterenol Sensitivity Test

• Registration Number: NCT02286934
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-05
• Primary Completion: 2014-11
• Study First Submitted QC: 2014-11-07
• Study First Posted: 2014-11-10
• Study Completion: 2014-12
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-02
• Last Update Posted: 2015-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Carvedilol	Isoproterenol Sensitivity Test	* 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.
Carvedilol	Carvedilol	* 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.

Primary Outcome Measures

Name	Time	Method
AUC (area under the plasma concentration-time curve) of carvedilol	predose and 0.25, 0.5, 1, 2, 3, 4, 6, 12, 24h postdose
Cmax (Maximum plasma concentration) of carvedilol	predose and 0.25, 0.5, 1, 2, 3, 4, 6, 12, 24h postdose

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyounggi, Korea, Republic of