UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018174
Receipt number R000021053
Scientific Title Clinical pharmacological study of TM5509 -Clinical pharmacological study in male mild obesity subjects-
Date of disclosure of the study information 2015/08/10
Last modified on 2015/11/10 14:01:27

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Basic information

Public title

Clinical pharmacological study of TM5509
-Clinical pharmacological study in male mild obesity subjects-

Acronym

Clinical pharmacological study of TM5509
-Clinical pharmacological study in male mild obesity subjects- (TM5509-6)

Scientific Title

Clinical pharmacological study of TM5509
-Clinical pharmacological study in male mild obesity subjects-

Scientific Title:Acronym

Clinical pharmacological study of TM5509
-Clinical pharmacological study in male mild obesity subjects- (TM5509-6)

Region

Japan


Condition

Condition

Recover of hematogenesis after cord blood transplantation

Classification by specialty

Hematology and clinical oncology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Primary objective
Investigation for pharmacodynamics of TM5509 in Japanese male mild obesity subjects.

Secondary objective
Investigation for safety and pharmacokinetics of TM5509.

Basic objectives2

Pharmacodynamics

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase I


Assessment

Primary outcomes

Pharmacodynamics of TM5509

Key secondary outcomes

Safety and Pharmacokinetics of TM5509


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

step1
TM5509 (120mg, once a day for 3days)
washout period more than 3weeks
step2
placebo (once a day for 3days)

Interventions/Control_2

step1
placebo (once a day for 3days)
washout period more than 3weeks
step2
TM5509 (120mg, once a day for 3days)

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.Male Japanese
2.From 20 years old to 45 years old at voluntary written consent
3.From 50.0 kg to 90.0 kg and from 25.0 to 30.0 of BMI at screening
4.More than 20ng/ml of total PAI-1
5.Voluntary written consent by themselves is given before screening.

Key exclusion criteria

1.History of liver diseases, cardiovascular diseases, respiratory diseaases, gastroenteric diseases, kidney diseases, cerebralvascular diseases, cancer
2.Known hypersensitivity to some drugs and foods
3.More than grade 1 in liver function disorders
4.Treatment by other doctors (included supplement) within 14 days before screening
5.Treatment with any investigational compound within 120 days before screening
6.History of TM5509 administration
7.History of blood taken
*>= 1200ml of all blood within 1 year before screening
*>= 400ml of all blood with 84 days before screening
*>= 200ml of all blood within 14 days before screening
8.Smoking status and treatment with anti-nicotine agents
9.Known active chronic hepatitis B or C, active syphilis and human immunodeficiency virus infection
10.Abuse of alcohol or drugs (included past history)
11.Bleeding, in the tendency to bleeding, and family history and past history of bleeding disorders
12.Somebody who are directed by principle investigator and employees in Hamamatsu University hospital
13.Any serious medical or psychiatric illness that could, in the opinion of the investigator, potentially interfere with the completion of treatment according to this protocol.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuo Umemura

Organization

Hamamatsu University Hospital

Division name

Center for clinical research

Zip code


Address

1-20-1 Handayama Higashiku Hamamatsu

TEL

053-435-2006

Email

umemura@hama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazuo Umemura

Organization

Hamamatsu University Hospital

Division name

Center for clinical research

Zip code


Address

1-20-1 Handayama Higashiku Hamamatsu

TEL

053-435-2006

Homepage URL


Email

umemura@hama-med.ac.jp


Sponsor or person

Institute

Tohoku university school of medicine, molecular medicine and therapy, Toshio Miyata

Institute

Department

Personal name



Funding Source

Organization

ministry of health, labour and welfare

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

2015年7月7日


Institutions

Institutions

浜松医科大学附属病院(静岡県)


Other administrative information

Date of disclosure of the study information

2015 Year 08 Month 10 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

2015 Year 08 Month 05 Day

Date of IRB


Anticipated trial start date

2015 Year 08 Month 18 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 07 Month 03 Day

Last modified on

2015 Year 11 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021053


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name