UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024972 |
|---|---|
| Receipt number | R000028737 |
| Scientific Title | Phase 1 study of TM5614 -placebo controlled multiple dose study in male healthy adult subjects- |
| Date of disclosure of the study information | 2017/01/06 |
| Last modified on | 2017/03/30 09:43:46 |
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Basic information
Public title
Phase 1 study of TM5614
-placebo controlled multiple dose study in male healthy adult subjects-
Acronym
Placebo controlled multiple dose study in male healthy adult subjects (TM5614-2)
Scientific Title
Phase 1 study of TM5614
-placebo controlled multiple dose study in male healthy adult subjects-
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Kazuo Umemua |
Organization
Hamamatsu University Hospital
Division name
Center for clinical research
Zip code
Address
1-20-1 Handayama Higashi-ku, Hamamatsu, Japan
TEL
053-435-2006
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 Higashi-ku, Hamamatsu, Japan
TEL
053-435-2006
Homepage URL
http://hama-ccr.jp/
umemura@hama-med.ac.jp
Sponsor or person
Institute
Tohoku university school of medicine, molecular medicine and therapy
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2017 | Year | 01 | Month | 06 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028737
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| Registered date | File name |
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| Registered date | File name |
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