An Open-label, Single-dose, Two-treatment, Randomized, Cross-over Study to Investigate the Effects of the SLCO2B1 c.1457C>T Polymorphism and Apple Juice on the Pharmacokinetics and Pharmacodynamics of Acebutolol in Healthy Korean and Japanese Volunteers
1 other identifier
interventional
16
2 countries
2
Brief Summary
An open-label, single-dose, two-treatment, randomized, cross-over study to investigate the effects of the SLCO2B1 c.1457C\>T polymorphism and apple juice on the pharmacokinetics and pharmacodynamics of acebutolol in healthy Korean and Japanese volunteers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 healthy
Started Jan 2012
Shorter than P25 for phase_4 healthy
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 17, 2012
CompletedFirst Posted
Study publicly available on registry
January 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedJune 20, 2012
June 1, 2012
4 months
January 17, 2012
June 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
AUC of acebutolol 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.
0-24 hr after drug administration
Secondary Outcomes (1)
Blood pressure of the subjects who administered acebutolol according to the SLCO2B1 genotypes
0-24 hr after drug admnistration
Study Arms (2)
Acebutolol
EXPERIMENTALAcebutolol 200 mg capsule (Acetanol®)
Placebo
PLACEBO COMPARATORInterventions
Placebo capsule(Capsules filled up with lactose)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- A subject with history of allergies including study drug (acebutolol) or other drug allergies (aspirin, antibiotics, etc.), or history of clinically significant allergies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- In-Jin Jang, MD, PhDlead
- Oita Universitycollaborator
- Seoul National University Hospitalcollaborator
- Kyushu Universitycollaborator
Study Sites (2)
General Clinical Research Center, Oita University Hospital
Ōita, Japan
Seoul National University Hospital
Seoul, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kyoichi Ohashi, MD, PhD
Department of Clinical Pharmacology and Therapeutics, Oita University Faculty of Medicine, Oita, Japan
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Clinical Pharmacology and Therapeutics
Study Record Dates
First Submitted
January 17, 2012
First Posted
January 20, 2012
Study Start
January 1, 2012
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
June 20, 2012
Record last verified: 2012-06