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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Atenolol
* Drug: Atenolol with apple juice 1200 mL
* Drug: Atenolol with apple juice 600 mL


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC of atenolol according to the SLCO2B1 genotypes | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SLCO2B1 genotype, effect of apple juice