UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029889 |
|---|---|
| Receipt number | R000034142 |
| Scientific Title | Pharmacokinetics of breath alcohol and acetaldehyde after drinking alcohol |
| Date of disclosure of the study information | 2017/11/08 |
| Last modified on | 2025/12/19 11:40:31 |
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Basic information
Public title
Pharmacokinetics of breath alcohol and acetaldehyde after drinking alcohol
Acronym
Pharmacokinetics of breath alcohol and acetaldehyde after drinking alcohol
Scientific Title
Pharmacokinetics of breath alcohol and acetaldehyde after drinking alcohol
Scientific Title:Acronym
Pharmacokinetics of breath alcohol and acetaldehyde after drinking alcohol
Region
| Japan |
Condition
Condition
A healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To elucidate a relationship between pharmacokinetics of breath alcohol and acetaldehyde after drinking and alcohol sensitivity (ALDH2 and ADH1B genotypes)
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
changes in breath alcohol and acetaldehyde concentrations after drinking alcohol
Key secondary outcomes
Alcohol sensitivity by alcohol patch test and ADH1B/ALDH2 genotypes based on PCR method using oral mucosa.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Intervention is 3 days. On each day, a subject intakes 180ml alcohol beverage of different 3 concentrations (0.01g/kg of body weight (BW), 0.1g/kg of BW, 0.3g/kg of BW or 0.5g/kg of BW ethanol) within about 5 minutes. And then, he is sampled his exhaled gas over time (every 5-20 minutes) for 1 hour, 2.5 hours or 4 hours, respectively.
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
･20<= years-old
･Male and Female
･A person who has ever drunken a unit of alcohol.
･A person who is standard weight (=>18.5 and <25) based on BMI (body mass index)
･A person who is provided sufficient explanations about this study and consented to it in writing by his own free will
Key exclusion criteria
･a person who has ever had any allergy symptoms by drinking alcohol beverage
･a person who has any airway diseases or liver diseases
･a person who is probably pregnant or is during pregnancy
･a person who is during the lactation
･an inappropriate person for this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ayako |
| Middle name | |
| Last name | Himemiya-Hakucho |
Organization
Graduate School of Medicine, Yamaguchi University
Division name
Department of Legal Medicine
Zip code
755-8505
Address
Minami-kogushi 1-1-1, Ube, Yamaguchi 755-8505 JAPAN
TEL
0836-22-2234
fujimiya@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Ayako |
| Middle name | |
| Last name | Himemiya-Hakucho |
Organization
Graduate School of Medicine, Yamaguchi University
Division name
Department of Legal Medicine
Zip code
755-8505
Address
Minami-kogushi 1-1-1, Ube, Yamaguchi 755-8505 JAPAN
TEL
0836-22-2234
Homepage URL
haku.a@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center For Clinical Research, Yamaguchi University Hospital
Address
Minami-kogushi 1-1-1, Ube, Yamaguchi 755-8505 JAPAN
Tel
0836-22-2428
me223@yamaguchi-u.ac.jp
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
山口大学医学部（山口県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 08 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
95
Results
Ongoing
Results date posted
| 2025 | Year | 12 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A healthy adult
･20<= years-old
･Male and Female
･A person who has ever drunken a unit of alcohol.
･A person who is standard weight (=>18.5 and <25) based on BMI (body mass index)
･A person who is provided sufficient explanations about this study and consented to it in writing by his own free will
Participant flow
Intervention is 3 days. On each day, a subject intakes 180ml alcohol beverage of different 3 concentrations (0.01g/kg of body weight (BW), 0.1g/kg of BW, 0.3g/kg of BW or 0.5g/kg of BW ethanol) within about 5 minutes. And then, he is sampled his exhaled gas over time (every 5-20 minutes) for 1 hour, 2.5 hours or 4 hours, respectively.
Adverse events
None.
Outcome measures
changes in breath alcohol and acetaldehyde concentrations after drinking alcohol
Alcohol sensitivity by alcohol patch test and ADH1B/ALDH2 genotypes based on PCR method using oral mucosa
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2017 | Year | 09 | Month | 19 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 08 | Day |
Last modified on
| 2025 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034142
