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

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 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


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

Value
https://center6.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