UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006918 |
|---|---|
| Receipt number | R000008173 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2011/12/21 |
| Last modified on | 2012/12/20 09:24:42 |
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Basic information
Public title
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
Acronym
The effects of the SLCO2B1 polymorphism and apple juice on the pharmacokinetics and pharmacodynamics of acebutolol in healthy Korean and Japanese
volunteers
Scientific Title
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
Scientific Title:Acronym
The effects of the SLCO2B1 polymorphism and apple juice on the pharmacokinetics and pharmacodynamics of acebutolol in healthy Korean and Japanese
volunteers
Region
| Japan | Asia(except Japan) |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate the effect of SLCO2B1 genotypes and apple juice on pharmacokinetic and
pharmacodynamics of acebutolol after a single oral dose
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Pharmacokinetic parameters of acebutolol
2) Blood pressure and pulse rate
Key secondary outcomes
Adverse drug reactions
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Placebo - (Wash out period) - Acebutolol with water - (Wash out period) - Acebutolol with apple juice
Interventions/Control_2
Placebo - (Wash out period) - Acebutolol with apple juice - (Wash out period) - Acebutolol with water
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) A subject with body weight between 45 kg (inclusive) and 80 kg (exclusive) for female, and between 50 kg (inclusive) and 90 kg (exclusive) for male, and body mass index (BMI) between 17 (inclusive) and 28 (exclusive) for both gender.
2) Findings within the range of clinical acceptability in medical history and physical examination, and laboratory results within the laboratory reference ranges for the relevant laboratory tests (including the case that the investigator considers the deviation to be irrelevant for the purpose of the study)
5) A subject who has the*4/*4 genotype of N-acetyltransferase-2
Key exclusion criteria
1) A subject with history of allergies including study drug (acebutolol) or other drug allergies (aspirin, antibiotics, etc.), or history of clinically significant allergies
2) A subject with clinical evidence or history of hepatic (including carrier of hepatitis virus), renal, gastrointestinal, respiratory (including asthma and COPD), endocrine, neurologic, immunologic, hematologic, oncologic, psychiatric, or cardiovascular
disease
3) A subject with a history of surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug
4) A subject whose systolic blood pressure (SBP): < or = 100 mmHg, or > or = 140 mmHg, diastolic blood pressure (DBP): < or = 40 mmHg, or > pr = 90 mmHg, pulse rate (PR): < or =50/min, or > or = 100 /min
5) A subject who has taken any prescribed medication or herbal compounds
6) A subject who has taken any type of fruit or its juice (apple juice, grapefruit juice, orange juice, grape, etc.) within 7 days prior to the study drug administration
7) A smoker (except for whom quitted smoking prior to the drug administration for at least 3 months)
8) A female subject who are pregnant or breast feeding
9) A female subject who does not agree to use routinely adequate contraception
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kyoichi Ohashi |
Organization
Oita University Faculty of Medicine
Division name
Department of Clinical Pharmacology and Therapeutics
Zip code
Address
1-1 Idaigaoka Hasama-machi, Yufu 879-5593, Japan
TEL
097-586-5952
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsutomu Kotegawa |
Organization
Oita University Faculty of Medicine
Division name
Department of Clinical Pharmacology and Therapeutics
Zip code
Address
1-1 Idaigaoka Hasama-machi, Yufu 879-5593, Japan
TEL
097-586-5952
Homepage URL
http://www.med.oita-u.ac.jp/gcrc-oita/
kotet@oita-u.ac.jp
Sponsor or person
Institute
General Clinical Research Center, Oita University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Clinical Trials Center, Seoul National University Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
大分大学医学部附属病院総合臨床研究センター
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 11 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2012 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 20 | Day |
Last modified on
| 2012 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008173
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
