UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007296 |
|---|---|
| Receipt number | R000008542 |
| Scientific Title | Safety and pharmacokinetic assessment of [11C]ketoprofen methylester in healthy volunteers |
| Date of disclosure of the study information | 2012/02/16 |
| Last modified on | 2012/08/11 15:52:55 |
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Basic information
Public title
Safety and pharmacokinetic assessment of [11C]ketoprofen methylester in
healthy volunteers
Acronym
KET-1
Scientific Title
Safety and pharmacokinetic assessment of [11C]ketoprofen methylester in
healthy volunteers
Scientific Title:Acronym
KET-1
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Radiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
First -in-human study of [11C]ketoprofen-methylester.
Assessment of safety, pharmacokinetics and dosimetry in healthy volunteers.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Safety, Pharmacokinetics, Dosimetry
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
The dosage in the vein of [11C] ketoprofen methylester for PET imaging.
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
1. The subject who has intention to participate in this study, and singed informed consent.
2. Male subject of >=20 and <45 years old, with body weight >=50kgt and <85kg, and BMI >=17.6 and <26.4.
3. The subject who was judged by clinical investigator by means of physical examination and Laboratory tests to be eligible as a participant in this study.
Key exclusion criteria
1)The subject who has a peptic ulcer.
2)The subject who has blood abnormality.
3)The subject who has dysfunction in the liver / kidney.
4)The subject who has cerebrovascular disorder.
5)The subject having cardiac failure.
6)The subject with WPW or LGL syndrome, or marked bradycardia, in electrocardiogram.
7)The subject with a history of a drug or food allergy.
8)The subject who was judged by the clinical investigator to be inappropriate as a participant in this study.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michio Senda |
Organization
Institute of Biomedical Research and Innovation
Division name
Division of Molecular Imaging
Zip code
Address
2-2, Minatojima minamimachi, chuo-ku, Kobe, Hyogo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michio Senda |
Organization
Institute of Biomedical Research and Innovation
Division name
Division of Molecular Imaging
Zip code
Address
2-2, Minatojima minamimachi, chuo-ku, Kobe, Hyogo
TEL
Homepage URL
senda@fbri.org
Sponsor or person
Institute
Division of Molecular Imaging, Institute of Biomedical Research and Innovation
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
RIKEN
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
財団法人先端医療振興財団 先端医療センター
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 16 | 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
| 2012 | Year | 02 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 08 | Month | 09 | Day |
Date of closure to data entry
| 2012 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 15 | Day |
Last modified on
| 2012 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008542
