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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002220
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute APDD
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002726

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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