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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
In-Jin Jang, MD, PhD, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01445964
First received: April 29, 2011
Last updated: January 20, 2012
Last verified: January 2012
History of Changes
  Purpose

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 Intervention Phase
Healthy
 Drug: Atenolol
Drug: Atenolol with apple juice 1200 mL
Drug: Atenolol with apple juice 600 mL
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • AUC of atenolol according to the SLCO2B1 genotypes [ Time Frame: 0-48 hr after drug administration ] [ Designated as safety issue: No ]
    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:
  • Blood pressure of the subjects who administered atenolol according to the SLCO2B1 genotypes [ Time Frame: 0-48 hr after drug admnistration ] [ Designated as safety issue: Yes ]
    Blood pressure measurement will be presented as descriptive statistics for the difference from baseline where appropriate.

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 0-48 hr after drug admnistration ] [ Designated as safety issue: Yes ]

    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.



Enrollment: 12
Study Start Date: May 2011
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01445964

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

No publications provided

Responsible Party: In-Jin Jang, MD, PhD, Professor of Clinical Pharmacology and Therapeutics, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01445964     History of Changes
Other Study ID Numbers: SNUCPT11_ATE, Pan Asian-Atenolol-1
Study First Received: April 29, 2011
Last Updated: January 20, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
SLCO2B1 genotype
effect of apple juice

Additional relevant MeSH terms:
Atenolol
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on May 19, 2013