UMIN-CTR Clinical Trial

Public title

Phase 1 study of TM5614
-placebo controlled single dose study in male healthy adult subjects

Acronym

placebo controlled single dose study in male healthy adult subjects (TM5614-1)

Scientific Title

Phase 1 study of TM5614
-placebo controlled single dose study in male healthy adult subjects

Scientific Title:Acronym

placebo controlled single dose study in male healthy adult subjects (TM5614-1)

Region

Japan

Condition

Chronic myelogenous leukemia

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

Primary objective
Investigation for safety of TM5614 in Japanese male healthy adult subjects.

Secondary objective
Investigation for pharmacokinetics and pharmacodynamics of TM5614

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Safety of TM5614(until 7 days after the administration)
Vital sign,
Electrocardiogram
laboratory examination
adverse event

Key secondary outcomes

Pharmacokinetics and pharmacodynamics of TM5614(until 48 hours after the administration)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

TM5614 (30, 60, 120, 240mg, single dose)

Interventions/Control_2

Placebo (single dose)

Interventions/Control_3

TM5614 (60mg, single dose) after meal

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 85.0 kg and from 18.5 to 25.0 of BMI at screening
4. 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. Treatment by other doctors (included supplement) within 14 days before screening
4. Treatment with any investigational compound within 120 days before screening
5. 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
6. Smoking status and treatment with anti-nicotine agents
7. Known active chronic hepatitis B or C, active syphilis and human immunodeficiency virus infection
8. Abuse of alcohol or drugs (included past history)
9. Bleeding, in the tendency to bleeding, and family history and past history of bleeding disorders
10. Somebody who are directed by principle investigator and employees in Hamamatsu University hospital
11. 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

32

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

Handayama 1-20-1, Higashi-ku, Hamamatsu, Japan

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

Handayama 1-20-1, Higashi-ku, Hamamatsu, Japan

TEL

053-435-2006

Homepage URL

http://hama-ccr.jp/tr/

Email

umemura@hama-med.ac.jp

Institute

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

Institute

Department

Personal name

Organization

Japan agency for medical research and development

Organization

Division

Category of Funding Organization

Japanese Governmental office

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

Institutions

浜松医大大学病院(静岡県)

Date of disclosure of the study information

2016

Year

01

Month

08

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

2016

Year

01

Month

08

Day

Date of IRB

Anticipated trial start date

2016

Year

01

Month

22

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

12

Month

01

Day

Last modified on

2016

Year

12

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023111