Cytochrome P450 2D6 Genotype on the Clinical Effect of Carvedilol

June 2, 2015 updated by: Jae Yong Chung, Seoul National University Hospital

A Clinical Trial to Investigate the Influence of Cytochrome P450 2D6 Polymorphism on the Pharmacokinetic/Pharmacodynamics Characteristics of Carvedilol in Healthy Korean Volunteers

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyounggi
      • Seongnam, Gyounggi, Korea, Republic of
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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
Other: Isoproterenol Sensitivity Test
Day 0, 1, 8 : Isoproterenol Sensitivity Test

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

National Institute of Food and Drug Safety Evaluation, Korea

Investigators

  • Principal Investigator: Jae-Yong Chung, MD, PhD, Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang Hospital, Seongnam, Kore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

September 5, 2014

First Submitted That Met QC Criteria

November 7, 2014

First Posted (Estimate)

November 10, 2014

Study Record Updates

Last Update Posted (Estimate)

June 4, 2015

Last Update Submitted That Met QC Criteria

June 2, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CYP-CVDL-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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