UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002220 |
|---|---|
| Receipt number | R000002726 |
| Scientific Title | Use of accelerator Mass Spectrometry to measure the pharmacokinetics and metablites analysis of C14-labled tolbutamide |
| Date of disclosure of the study information | 2009/07/23 |
| Last modified on | 2009/11/05 16:17:50 |
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Basic information
Public title
Use of accelerator Mass Spectrometry to measure the pharmacokinetics and metablites analysis of C14-labled tolbutamide
Acronym
Use of accelerator Mass Spectrometry to measure the pharmacokinetics and metablites analysis of C14-labled tolbutamide
Scientific Title
Use of accelerator Mass Spectrometry to measure the pharmacokinetics and metablites analysis of C14-labled tolbutamide
Scientific Title:Acronym
Use of accelerator Mass Spectrometry to measure the pharmacokinetics and metablites analysis of C14-labled tolbutamide
Region
| Japan |
Condition
Condition
healthy volunteer
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure tolbutamide pharmacokinetics and human metabolites by C14-labeled tolbutamide(100µg, 7400Bq) oral administration.
Parent and metabolites of tolbutamide are separeted and detected by AMS and metabolites structure analysis is evaluated by LC/MS/MS. SNPs effect on those profiles is also analyzed.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
general feasibility of microdose clinical trail using AMS based on evaluated data compared with known data and parameters.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
oral administration of C14-tolbutamide
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
| 45 | years-old | > |
Gender
Male
Key inclusion criteria
the investigators must ensure that all subjects being considerd meet the following inclusion criteria
1)capable to understand and sign the informed consent.
2)20-45 years of age
3)BMI 18.5-25.0
4)good health as determined by physical examination, vital signs and laboratory tests.
5)CYP2C9 SNP's classified in EM(*1/*1) or IM(*1/*3)
Key exclusion criteria
the investigators must ensure that all subjects being considered meet the following exclusion criteria or conditions
1)diabetes or blood glucose abnormality
2)dysemia
3)history of cardiac disease
4)impairmant of liver or kidney functions
5)any medical condition that reqires medical attention
6)recent (past 4 months) participation in other clinical trial and the investigator determines this trial participation inadequate
7)history of allergy to tolbutamide
8)donation of 400mL or more of blood within 3 months prior to participation, donation of 200mL or more of blood within 1 month prior to participation, or donation of component blood within 2 weeks prior to participation
9)positive serologic reaction of syphilis, positive results of HIV test, HBsAg and HCVAb
10)history of multiple and recurning allergies to medicines or food
11)history of drug or alcohol abuse
12)the investigator determines this trial participation inadequate
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Setsuo Hasegawa |
Organization
Sekino Clinical Pharmacology Clinic
Division name
Sekino Clinical Pharmacology Clinic
Zip code
Address
3-28-3 Ikebukuro, Toshima-ku Tokyo
TEL
03-5396-4505
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kainuma Michiko |
Organization
Sekino Clinical Pharmacology Clinic
Division name
Sekino Clinical Pharmacology Clinic
Zip code
Address
3-28-3 Ikebukuro, Toshima-ku Tokyo
TEL
03-5396-4530
Homepage URL
Sponsor or person
Institute
APDD
Institute
Department
Personal name
Funding Source
Organization
APDD
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 07 | Month | 23 | 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
| 2009 | Year | 07 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 07 | Month | 17 | Day |
Last modified on
| 2009 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002726
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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