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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01445964
Recruitment Status : Completed
First Posted : October 4, 2011
Last Update Posted : January 23, 2012
Sponsor:
Information provided by (Responsible Party):
In-Jin Jang, MD, PhD, Seoul National University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Atenolol Drug: Atenolol with apple juice 1200 mL Drug: Atenolol with apple juice 600 mL Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 Start Date : May 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Atenolol

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.




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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01445964


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: In-Jin Jang, MD, PhD Seoul National University Hospital

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Responsible Party: In-Jin Jang, MD, PhD, Professor of Clinical Pharmacology and Therapeutics, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01445964    
Other Study ID Numbers: SNUCPT11_ATE
Pan Asian-Atenolol-1
First Posted: October 4, 2011    Key Record Dates
Last Update Posted: January 23, 2012
Last Verified: January 2012
Keywords provided by In-Jin Jang, MD, PhD, Seoul National University Hospital:
SLCO2B1 genotype
effect of apple juice
Additional relevant MeSH terms:
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Atenolol
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action