UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022455 |
|---|---|
| Receipt number | R000025847 |
| Scientific Title | Study of changes in blood and urine purine compounds by the administration of SG-1 (Compound A and B) or either of them. |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2017/12/20 12:35:14 |
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Basic information
Public title
Study of changes in blood and urine purine compounds by the administration of SG-1 (Compound A and B) or either of them.
Acronym
Effects of SG-1 on purine compounds
Scientific Title
Study of changes in blood and urine purine compounds by the administration of SG-1 (Compound A and B) or either of them.
Scientific Title:Acronym
Effects of SG-1 on purine compounds
Region
| Japan |
Condition
Condition
Normal adult males
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To observe the changes of blood and urine purine compounds by the administration of SG-1 or either compound A or B alone.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes of blood and urine purine compounds at 14 days after the daily administration of drugs
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
8
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
SG-1 (20 mg compound A and 0.5 g compound B) is administered to 1 subject twice a day for 14 days
Interventions/Control_2
20 mg compound A is administered to 3 subjects twice a day for 14 days
Interventions/Control_3
0.5 g compound B is administered to 3 subjects twice a day for 14 days
Interventions/Control_4
SG-1 (20 mg compound A and 0.5 g compound B) is administered to 3 subjects twice a day for 14 days
Interventions/Control_5
SG-1 (20 mg compound A and 1 g compound B) is administered to 3 subjects twice a day for 14 days
Interventions/Control_6
30 mg compound A is administered to 3 subjects twice a day for 14 days
Interventions/Control_7
SG-1 (30 mg compound A and 1 g compound B) is administered to 3 subjects twice a day for 14 days
Interventions/Control_8
SG-1 (30 mg compound A and 1.5 g compound B) is administered to 3 subjects twice a day for 14 days
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Healthy adult Japanese male
2) Subject with the ability to express his consent who, after a full explanation of the objective and contents of the present clinical study, has voluntarily expressed his consent to participate in the present clinical study.
3) Japanese subject with the age on the day of informed consent of not lower than 20 and not higher than 40.
4) Subject whose BMI is not lower than 17.6 and lower than 26.5 on the day of screening).
Key exclusion criteria
1) Routine user of medicine or supplement.
2) Subject who is currently being treated.
3) Subject who has or had renal function disorder.
4) Subject with a history of gout, hyperuricemia or urolithiasis.
5) Subject who has a history of renal disorder.
6) Subject who has or had hypersensitivity, idiosyncracy (allergy) to drug.
7) Subject with a disease or a disorder in heart, kidney, pulmonary organ, digestive organ or blood function that are considered to affect absorption, distribution, metabolism or excretion of a drug.
8) Subject who participated in another clinical study for a drug with a new compound within 4 weeks before the administration of drug in the present sduty.
9) Subject who donated 400 mL of blood within 12 weeks, 200 mL of blood within 4 weeks or blood components within 2 weeks.
10) Subject who used other drugs (including herbs) or supplements within 2 weeks before the administration of drug in this study.
11) Sujbect who plans to take other drugs (including herbs) or supplements before the end of the present study.
12) Subject who was judged not to be appropriate by the principal investigator or sub investigators by other reasons.
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoyuki Kamatani |
Organization
Tsukuba International Clinical Pharmacology Clinic
Division name
Doctors' office
Zip code
Address
1-21-16 Kan-nondai Tsukuba City, Ibaraki Prefecture
TEL
029-839-1150
kamatani@msb.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masanori Suzuki |
Organization
Tsukuba International Clinical Pharmacology Clinic
Division name
Division for Volunteers
Zip code
Address
1-21-16 Kan-nondai Tsukuba City, Ibaraki Prefecture
TEL
029-839-1150
Homepage URL
m-suzuki@tsukuba-icp.jp
Sponsor or person
Institute
Tsukuba International Clinical Pharmacology Clinic
Institute
Department
Personal name
Funding Source
Organization
StaGen Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
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
| 2016 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/gnam/41/2/41_171/_pdf/
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
| 2016 | Year | 02 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 23 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 25 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 05 | Month | 24 | Day |
Date analysis concluded
| 2016 | Year | 05 | Month | 24 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 25 | Day |
Last modified on
| 2017 | 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=R000025847
