UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase 1 study of TM5614 -placebo controlled multiple dose study in male healthy adult subjects-
Title of the study (Brief title)	Placebo controlled multiple dose study in male healthy adult subjects (TM5614-2)
Region	Japan

Condition
Condition	Chronic myelogenous leukemia
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
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	Exploratory
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	Safety of TM5614(until 7 days after the last administration) Vital sign, Electrocardiogram Laboratory examination Adverse event
Key secondary outcomes	Pharmacokinetics and pharmacodynamics of TM5614 (until 96 hours after the administration)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	TM5614 (60, 120mg,once a day for 7 days)
Interventions/Control_2	Placebo (once a day for 7 days)
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 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. 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. 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 TM5614 administration 6. 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 7. Smoking status and treatment with anti-nicotine agents 8. Known active chronic hepatitis B or C, active syphilis and human immunodeficiency virus infection 9. Abuse of alcohol or drugs (included past history) 10. Bleeding, in the tendency to bleeding, and family history and past history of bleeding disorders 11. Somebody who are directed by principle investigator and employees in Hamamatsu University hospital 12. 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	18

Research contact person
Name of lead principal investigator	Kazuo Umemua
Organization	Hamamatsu University Hospital
Division name	Center for clinical research
Address	1-20-1 Handayama Higashi-ku, Hamamatsu, Japan
TEL	053-435-2006
Email	umemura@hama-med.ac.jp

Public contact
Name of contact person	Kazuo Umemura
Organization	Hamamatsu University Hospital
Division name	Center for clinical research
Address	1-20-1 Handayama Higashi-ku, Hamamatsu, Japan
TEL	053-435-2006
Homepage URL	http://hama-ccr.jp/
Email	umemura@hama-med.ac.jp

Sponsor
Institute	Tohoku university school of medicine, molecular medicine and therapy
Institute
Department

Funding Source
Organization	AMED
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 01 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 06 Day
Anticipated trial start date	2017 Year 01 Month 12 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete	2017 Year 06 Month 30 Day
Date analysis concluded	2017 Year 08 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 11 Month 24 Day
Last modified on	2017 Year 03 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028737