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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022455
Receipt No. 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

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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
Email 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
Email m-suzuki@tsukuba-icp.jp

Sponsor
Institute Tsukuba International Clinical Pharmacology Clinic
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025847

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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