Effect of SLCO2B1 Genotype and Apple Juice on Pharmacokinetics of Atenolol After Oral Administration in Healthy Male Korean

January 20, 2012 updated by: In-Jin Jang, MD, PhD, Seoul National University Hospital

An Open-label, Single-dose, Three-treatment, Three-period Study to Investigate the Effect of SLCO2B1 Genotype and Apple Juice on Pharmacokinetics of Atenolol After Oral Administration in Healthy Male Korean

An open-label, single-dose, three-treatment, three-period study to investigate the effect of SLCO2B1 genotype and apple juice on pharmacokinetics of atenolol after oral administration in healthy male Korean.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 4

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

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

16 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB) - approved informed consent prior to performing any of the screening procedures

Exclusion Criteria:

  • A subject with history of allergies including study drug (atenolol) or other drug allergies (aspirin, antibiotics, etc.), or history of clinically significant allergies

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
SLCO2B1 wild type allele
Drug: Atenolol
Atenolol oral administration
Drug: Atenolol with apple juice 1200 mL
Atenolol oral administration with apple juice 1200 mL
Drug: Atenolol with apple juice 600 mL
Atenolol oral administration with apple juice 600 mL
Experimental: 2
SLCO2B1 variant allele
Drug: Atenolol
Atenolol oral administration
Drug: Atenolol with apple juice 1200 mL
Atenolol oral administration with apple juice 1200 mL
Drug: Atenolol with apple juice 600 mL
Atenolol oral administration with apple juice 600 mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC of atenolol according to the SLCO2B1 genotypes
Time Frame: 0-48 hr after drug administration
The area under the plasma concentration versus time curve, from time 0 to the last measurable concentration, as calculated by the linear/log trapezoidal method will be summarized by treatment and genotype group using descriptive statistics.
0-48 hr after drug administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure of the subjects who administered atenolol according to the SLCO2B1 genotypes
Time Frame: 0-48 hr after drug admnistration
Blood pressure measurement will be presented as descriptive statistics for the difference from baseline where appropriate.
0-48 hr after drug admnistration
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 0-48 hr after drug admnistration

Number of participants with adverse event as a measure of safety and tolerability

*Measure of safety and tolerability: physical examinations, ECG, Laboratory tests (including hematology, chemistry, urinalysis)

- Descriptive statistics will be calculated for quantitative safety data as well as for the difference from baseline where appropriate.
0-48 hr after drug admnistration

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: In-Jin Jang, MD, PhD, Seoul National University Hospital

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

May 1, 2011

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

April 29, 2011

First Submitted That Met QC Criteria

September 30, 2011

First Posted (Estimate)

October 4, 2011

Study Record Updates

Last Update Posted (Estimate)

January 23, 2012

Last Update Submitted That Met QC Criteria

January 20, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUCPT11_ATE
  • Pan Asian-Atenolol-1

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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