UMIN-CTR Clinical Trial

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

Recover of hematogenesis after cord blood transplantation

Classification by specialty

Hematology and clinical oncology

Adult

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Pharmacodynamics of TM5509

Key secondary outcomes

Safety and Pharmacokinetics of TM5509

Study type

Interventional

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

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

ministry of health, labour and welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

浜松医科大学附属病院（静岡県）

Date of disclosure of the study information

2015

Year

08

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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