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Recruitment status Completed
Unique ID issued by UMIN UMIN000020018
Receipt No. R000023111
Scientific Title Phase 1 study of TM5614 -placebo controlled single dose study in male healthy adult subjects
Date of disclosure of the study information 2016/01/08
Last modified on 2016/12/01

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Basic information
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
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
Trial characteristics_2
Developmental phase

Assessment
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)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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 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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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. 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

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

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

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Japan agency for medical research and development
Organization
Division
Category of Funding Organization Japanese Governmental office
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

Institutions
Institutions 浜松医大大学病院(静岡県)

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 08 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
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
Other related information

Management information
Registered date
2015 Year 12 Month 01 Day
Last modified on
2016 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023111


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