UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014940 |
|---|---|
| Receipt number | R000017369 |
| Scientific Title | A Multicenter, single blind, dose-escalation, Investigator initiated trial for single intravenous administration of NK-104-NP to male adult Healthy volunteers |
| Date of disclosure of the study information | 2014/08/25 |
| Last modified on | 2015/02/25 09:21:32 |
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Basic information
Public title
A Multicenter, single blind, dose-escalation, Investigator initiated trial for single intravenous administration of NK-104-NP to male adult Healthy volunteers
Acronym
Intravenous Administration of NK-104-NP to healthy volunteers
Scientific Title
A Multicenter, single blind, dose-escalation, Investigator initiated trial for single intravenous administration of NK-104-NP to male adult Healthy volunteers
Scientific Title:Acronym
Intravenous Administration of NK-104-NP to healthy volunteers
Region
| Japan |
Condition
Condition
Pulmonary Hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify dose showing safety when NK-104-NP containing 1,2,4,8 mg of pitavastatin calcium is intravenous administrated to male healthy volunteers, as well as to evaluated pharmacokinetics for the parent compound in plasma and urine.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Names, severity and incidence rate of adverse effect and adverse drug reactions.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
NK-104-NP 1mg
Interventions/Control_2
NK-104-NP 2mg
Interventions/Control_3
NK-104-NP 4mg
Interventions/Control_4
NK-104-NP 8mg
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
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
1)Healthy Male Japanese
2)A person aged 20yo to 40yo
3)A person with a BMI values under 18.5 or over 30.0
Key exclusion criteria
1)A person who has history of drug allergy.
2)A person who has hypersensitivity including allergy (except asymptomatic allergy).
3)A person who used other therapeutic drugs within 2 weeks or who needs other therapeutic drugs during the clinical trial participation period.
4)A person who used other OTC drugs within a week or who needs other OTC drugs during the clinical trial participation period.
5)A person who donated over 200 mL of whole blood within a month, who experienced plasmapheresis/platelet apheresis within 2 weeks or who donated over 400 mL of whole blood within 3 months.
6)A person who was entolled and given new drugs in other clinical trials within four months before this clinical trial or a person who participates in other clinical trials at the same time with this clinical trial.
7)A person whose percutaneous arterial oxygen saturation is less than 95%.
8)A person with alcohol or drug dependency.
9)A person who is positive for drug abuse tests.
10)A person who is positive for the following tests: HBs antigen, HCV antibody, HIV antigen/antibody or syphilis serum reaction.
11)A person who cannot prevent pregnancy during 6 months after this clinical trial.
12)A person assessed as ineligible for enrollment by investigators of this clinical trial.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Matoba |
Organization
Kyushu University Hospital
Division name
Department of Cardovascular Medicine
Zip code
Address
3-1-1 Maidashi, Higashi-ku,Fukuoka
TEL
092-642-6919
matoba@cardiol.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaku Nakano |
Organization
Kyushu University
Division name
Department of Cardiovascular Research, Development, and Translational Medicine
Zip code
Address
3-1-1 Maidashi, Higashi-ku,Fukuoka
TEL
092-642-6919
Homepage URL
kaku@cardiol.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
the Ministry of Health Labor and Welfare
Organization
Division
Category of Funding Organization
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
| 2014 | Year | 08 | Month | 25 | 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
| 2014 | Year | 08 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 03 | 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
| 2014 | Year | 08 | Month | 25 | Day |
Last modified on
| 2015 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017369
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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