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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019189
Receipt No. 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

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Basic information
Public 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
Acronym Repeated Intravenous Administration of NK-104-NP to healthy volunteers for seven days
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
Scientific Title:Acronym Repeated Intravenous Administration of NK-104-NP to healthy volunteers for seven days
Region
Japan

Condition
Condition Pulmonary Hypertension
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety: Names, severity and frequency of adverse effect and adverse drug reactions.
Pharmacokinetics: Concentrations of pitavastatin and pitavastatin lactone
Key secondary outcomes 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.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants 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 NK-104-NP 2 mg/body
Interventions/Control_2 NK-104-NP 4 mg/body
Interventions/Control_3 NK-104-NP 8 mg/body
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
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 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
Target sample size 30

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
Email 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
Email kaku@cardiol.med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University Hospital
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2015 Year 10 Month 01 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
2015 Year 07 Month 17 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 19 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 10 Month 01 Day
Last modified on
2016 Year 04 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022180

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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