Unique ID issued by UMIN | UMIN000019189 |
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Receipt number | R000022180 |
Scientific Title | A Multicenter, placebo-controlled single blind, dose-escalation, Investigator initiated trial for seven days repeated intravenous administration of NK-104-NP to healthy adult male volunteers for seven days |
Date of disclosure of the study information | 2015/10/01 |
Last modified on | 2016/04/04 09:14:12 |
A Multicenter, placebo-controlled single blind, dose-escalation, Investigator initiated trial for seven days repeated intravenous administration of NK-104-NP to healthy adult male volunteers for seven days
Repeated Intravenous Administration of NK-104-NP to healthy volunteers for seven days
A Multicenter, placebo-controlled single blind, dose-escalation, Investigator initiated trial for seven days repeated intravenous administration of NK-104-NP to healthy adult male volunteers for seven days
Repeated Intravenous Administration of NK-104-NP to healthy volunteers for seven days
Japan |
Pulmonary Hypertension
Cardiology |
Others
NO
In order to clarify the safety for repeated intravenous administration of NK-104-NP containing 2,4,8 mg of pitavastatin calcium to adult male healthy volunteers for seven days, as well as to evaluated pharmacokinetics for the parent compound in plasma and urine.
Safety
Safety: Names, severity and frequency of adverse effect and adverse drug reactions.
Pharmacokinetics: Concentrations of pitavastatin and pitavastatin lactone
Change of physiological functions (body temparature, blood pressure, plus SPO2),change of laboratory evidences, change of a chest X-ray examination and change of cardiac functions.
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Placebo
3
Treatment
Medicine |
NK-104-NP 2 mg/body
NK-104-NP 4 mg/body
NK-104-NP 8 mg/body
20 | years-old | <= |
40 | years-old | >= |
Male
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
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 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 dependence.
9)A person who is positive for drug abuse testing.
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.
13)A person who was administrated NK-104-NP in the past
30
1st name | |
Middle name | |
Last name | Tetsuya Matoba |
Kyushu University Hospital
Department of Cardovascular Medicine
3-1-1 Maidashi, Higashi-ku,Fukuoka
092-642-6919
matoba@cardiol.med.kyushu-u.ac.jp
1st name | |
Middle name | |
Last name | Kaku Nakano |
Kyushu University
Department of Cardiovascular Research, Development, and Translational Medicine
3-1-1 Maidashi, Higashi-ku,Fukuoka
092-642-6919
kaku@cardiol.med.kyushu-u.ac.jp
Kyushu University Hospital
Japan Agency for Medical Research and Development (AMED)
Non profit foundation
NO
2015 | Year | 10 | Month | 01 | Day |
Unpublished
Completed
2015 | Year | 07 | Month | 17 | Day |
2015 | Year | 10 | Month | 19 | Day |
2015 | Year | 10 | Month | 01 | Day |
2016 | Year | 04 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022180
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